Trial Outcomes & Findings for Protocolized Diuretic Strategy in Cardiorenal Failure (NCT NCT01921829)
NCT ID: NCT01921829
Last Updated: 2017-08-21
Results Overview
The change in body weight (kg) from randomization to day 4 or date of discharge will be determined by the difference between body weight at day 4 after randomization or date of discharge (whichever comes first) and body weight taken at baseline measured in the hospital on standard scales without shoes and wearing a hospital gown, measured before breakfast and post-voiding.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
4 days (96 hours)
Results posted on
2017-08-21
Participant Flow
Patients were recruited from the UPMC Heart Failure and Cardiology services, from July 2015-Nov 2016.
One participant was enrolled but withdrew consent before receiving any randomized treatment protocol. Therefore, that patient was withdrawn.
Participant milestones
| Measure |
Usual Care
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Usual Care
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Missing data
Baseline characteristics by cohort
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 8.6 • n=10 Participants
|
68.4 years
STANDARD_DEVIATION 6.9 • n=8 Participants
|
68.7 years
STANDARD_DEVIATION 7.3 • n=18 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=10 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=10 Participants
|
6 Participants
n=8 Participants
|
13 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=10 Participants
|
8 Participants
n=8 Participants
|
14 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Years of education
|
13.5 years
STANDARD_DEVIATION 2.3 • n=10 Participants
|
12.9 years
STANDARD_DEVIATION 2.4 • n=8 Participants
|
13.2 years
STANDARD_DEVIATION 2.3 • n=18 Participants
|
|
Smoking
Current
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Smoking
Past
|
5 Participants
n=10 Participants
|
6 Participants
n=8 Participants
|
11 Participants
n=18 Participants
|
|
Smoking
Never
|
5 Participants
n=10 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=18 Participants
|
|
Alcohol use
|
1 Participants
n=10 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=18 Participants
|
|
Caffeine use
|
8 Participants
n=9 Participants • Missing data
|
6 Participants
n=8 Participants • Missing data
|
14 Participants
n=17 Participants • Missing data
|
|
Cardiomyopathy type
Ischemic
|
5 Participants
n=10 Participants
|
5 Participants
n=8 Participants
|
10 Participants
n=18 Participants
|
|
Cardiomyopathy type
Dilated
|
1 Participants
n=10 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=18 Participants
|
|
Cardiomyopathy type
Hypertensive
|
0 Participants
n=10 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=18 Participants
|
|
Cardiomyopathy type
Other
|
4 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=18 Participants
|
|
NYHA Class
II
|
2 Participants
n=9 Participants • Missing data
|
2 Participants
n=6 Participants • Missing data
|
4 Participants
n=15 Participants • Missing data
|
|
NYHA Class
III
|
5 Participants
n=9 Participants • Missing data
|
4 Participants
n=6 Participants • Missing data
|
9 Participants
n=15 Participants • Missing data
|
|
NYHA Class
IV
|
2 Participants
n=9 Participants • Missing data
|
0 Participants
n=6 Participants • Missing data
|
2 Participants
n=15 Participants • Missing data
|
|
Left ventricular ejection fraction
20-25%
|
3 Participants
n=8 Participants • Missing data
|
2 Participants
n=7 Participants • Missing data
|
5 Participants
n=15 Participants • Missing data
|
|
Left ventricular ejection fraction
25-30%
|
0 Participants
n=8 Participants • Missing data
|
2 Participants
n=7 Participants • Missing data
|
2 Participants
n=15 Participants • Missing data
|
|
Left ventricular ejection fraction
30-35%
|
1 Participants
n=8 Participants • Missing data
|
0 Participants
n=7 Participants • Missing data
|
1 Participants
n=15 Participants • Missing data
|
|
Left ventricular ejection fraction
Unknown
|
4 Participants
n=8 Participants • Missing data
|
3 Participants
n=7 Participants • Missing data
|
7 Participants
n=15 Participants • Missing data
|
|
Right ventricular function
Normal
|
3 Participants
n=8 Participants • Missing data
|
5 Participants
n=6 Participants • Missing data
|
8 Participants
n=14 Participants • Missing data
|
|
Right ventricular function
Reduced
|
5 Participants
n=8 Participants • Missing data
|
1 Participants
n=6 Participants • Missing data
|
6 Participants
n=14 Participants • Missing data
|
|
Mitral regurgitation
|
4 Participants
n=7 Participants • Missing data
|
3 Participants
n=6 Participants • Missing data
|
7 Participants
n=13 Participants • Missing data
|
|
Tricuspid regurgitation
|
6 Participants
n=8 Participants • Missing data
|
4 Participants
n=6 Participants • Missing data
|
10 Participants
n=14 Participants • Missing data
|
|
Jugular venous pressure elevated
|
6 Participants
n=9 Participants • Missing data
|
7 Participants
n=8 Participants • Missing data
|
13 Participants
n=17 Participants • Missing data
|
|
Edema grade
2+
|
7 Participants
n=9 Participants • Missing data
|
2 Participants
n=7 Participants • Missing data
|
9 Participants
n=16 Participants • Missing data
|
|
Edema grade
3+
|
1 Participants
n=9 Participants • Missing data
|
3 Participants
n=7 Participants • Missing data
|
4 Participants
n=16 Participants • Missing data
|
|
Edema grade
Unknown
|
1 Participants
n=9 Participants • Missing data
|
2 Participants
n=7 Participants • Missing data
|
3 Participants
n=16 Participants • Missing data
|
|
Hypertension
|
9 Participants
n=10 Participants
|
7 Participants
n=8 Participants
|
16 Participants
n=18 Participants
|
|
Diabetes mellitus
|
5 Participants
n=9 Participants • Missing data
|
5 Participants
n=8 Participants • Missing data
|
10 Participants
n=17 Participants • Missing data
|
|
Chronic obstructive pulmonary disease
|
2 Participants
n=9 Participants • Missing data
|
3 Participants
n=8 Participants • Missing data
|
5 Participants
n=17 Participants • Missing data
|
|
Coronary artery disease
|
5 Participants
n=9 Participants • Missing data
|
6 Participants
n=8 Participants • Missing data
|
11 Participants
n=17 Participants • Missing data
|
|
Depression
|
2 Participants
n=9 Participants • Missing data
|
2 Participants
n=8 Participants • Missing data
|
4 Participants
n=17 Participants • Missing data
|
|
Stroke
|
4 Participants
n=9 Participants • Missing data
|
0 Participants
n=8 Participants • Missing data
|
4 Participants
n=17 Participants • Missing data
|
|
Peripheral vascular disease
|
4 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=18 Participants
|
|
Hyperlipidemia
|
5 Participants
n=9 Participants • Missing data
|
5 Participants
n=8 Participants • Missing data
|
10 Participants
n=17 Participants • Missing data
|
|
Atrial fibrillation
|
5 Participants
n=10 Participants
|
6 Participants
n=8 Participants
|
11 Participants
n=18 Participants
|
|
Coronary artery bypass surgery
|
3 Participants
n=9 Participants • Missing data
|
3 Participants
n=8 Participants • Missing data
|
6 Participants
n=17 Participants • Missing data
|
|
Implantable cardioverter defibrillator
|
5 Participants
n=10 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=18 Participants
|
|
Cardiac resynchronization therapy
|
1 Participants
n=9 Participants • Missing data
|
1 Participants
n=8 Participants • Missing data
|
2 Participants
n=17 Participants • Missing data
|
|
Diuretic dose
|
242.5 mg/day
STANDARD_DEVIATION 112.7 • n=10 Participants
|
166.3 mg/day
STANDARD_DEVIATION 55.5 • n=8 Participants
|
214.2 mg/day
STANDARD_DEVIATION 99.7 • n=18 Participants
|
|
Creatinine
|
1.9 mg/dL
STANDARD_DEVIATION 0.5 • n=10 Participants
|
2.2 mg/dL
STANDARD_DEVIATION 0.8 • n=8 Participants
|
2.0 mg/dL
STANDARD_DEVIATION 0.6 • n=18 Participants
|
|
Blood urea nitrogen
|
38.2 mg/dL
STANDARD_DEVIATION 12.5 • n=10 Participants
|
56.3 mg/dL
STANDARD_DEVIATION 38.8 • n=8 Participants
|
45.6 mg/dL
STANDARD_DEVIATION 27.1 • n=18 Participants
|
|
Brain natriuretic peptide
|
855.3 pg/mL
STANDARD_DEVIATION 690.7 • n=10 Participants
|
530.4 pg/mL
STANDARD_DEVIATION 363.7 • n=8 Participants
|
710.9 pg/mL
STANDARD_DEVIATION 578.5 • n=18 Participants
|
PRIMARY outcome
Timeframe: 4 days (96 hours)Population: One patient from ProDiuS arm withdrew before undergoing any randomized treatment.
The change in body weight (kg) from randomization to day 4 or date of discharge will be determined by the difference between body weight at day 4 after randomization or date of discharge (whichever comes first) and body weight taken at baseline measured in the hospital on standard scales without shoes and wearing a hospital gown, measured before breakfast and post-voiding.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
Change in Body Weight (kg) From Randomization to Day 4 or Date of Discharge (Whichever Comes First)
|
-2.07 kg
Standard Deviation 4.84
|
-6.12 kg
Standard Deviation 1.95
|
SECONDARY outcome
Timeframe: 1 monthPopulation: One participant from the ProDiuS arm withdrew consent before undergoing any randomized treatment.
Length of hospitalization will be ascertained from admission date to date of discharge.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
Length of Hospitalization
|
7.5 days
Standard Deviation 12.0
|
8.0 days
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Up to 3 months (assessed at 1 month and 3 months)Number of rehospitalizations for HF will be ascertained based on chart review of admissions with HF as a coded diagnosis, evidence of clinical volume overload, and treatment with intravenous diuretics.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
Number of Rehospitalizations for Heart Failure (HF)
|
3 hospitalizations
|
1 hospitalizations
|
SECONDARY outcome
Timeframe: Up to 3 months (assessed at 1 month and 3 months)Number of rehospitalizations will be ascertained based on chart review of admissions to any hospital after the index hospitalization
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
Number of Total Rehospitalizations
|
0.0 hospitalizations
Standard Deviation 1.0
|
0.5 hospitalizations
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Up to 3 months (assessed at 1 month and 3 months)All-cause mortality will be ascertained based on chart review of vital status (alive/dead) and cause of death.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=9 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
All-cause Mortality
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 1 month (measured at baseline and 1 mo)The change in cross-sectional area (CSA) of the right internal jugular vein (RIJV) pre- and post-Valsalva is a measurement of venous compliance and was determined noninvasively with Doppler ultrasound. An increase in RIJV CSA \>17% during Valsalva effectively rules out elevated right atrial pressure (RAP) and suggests effective volume removal or decongestion. The difference between baseline and 1 month values of change in RIJV CSA are reported.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
Difference From Baseline to 1 Month in Change in Right Internal Jugular Vein (RIJV) Cross-sectional Area (CSA) Pre- and Post-Valsalva
|
0.11 cm^2
Standard Deviation 1.03
|
0.22 cm^2
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Daily while in hospitalStrict intake (oral intake, intravenous medications, fluids, etc.) and output (urine, emesis, stools, drains, etc.) will be documented by the nurses on the HF floors per routine clinical protocol for all patients. Fluid balance will be determined by subtracting the volume of total intake from the volume of total output (in mL) over 24 hours (7 am to 7 am or the preceding 24-h period if no 7 am to 7 am period is available). Fluid balance and urine output will be ascertained by chart review daily during the intervention while the participants are hospitalized.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
Fluid Balance
|
-1077 mL/day
Standard Deviation 345
|
-590 mL/day
Standard Deviation 1268
|
SECONDARY outcome
Timeframe: Daily while in hospital, 1 mo & 3 mosAcute kidney injury will be defined based a rise in Cr ≥0.3 mg/dL.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
Acute Kidney Injury
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline to 1 monthThe Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. A 10 point decline in KCCQ scores has important prognostic significance in terms of survival.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Score Change at 1 Month
|
6.64 units on a scale
Standard Deviation 18.01
|
19.89 units on a scale
Standard Deviation 9.83
|
SECONDARY outcome
Timeframe: Baseline to 1 monthThe Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. A 10 point decline in KCCQ scores has important prognostic significance in terms of survival.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score Change at 1 Month
|
15.65 units on a scale
Standard Deviation 14.41
|
16.20 units on a scale
Standard Deviation 13.93
|
SECONDARY outcome
Timeframe: Baseline to 1 monthThe Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) is a well-validated generic HRQOL questionnaire that generates two composite scores: the Physical Component Score (PCS) and Mental Component Score (MCS). The PCS aggregates items from Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, and Social Functioning. The MCS aggregates items from Role-Emotional, Mental Health, General Health, Vitality, and Social Functioning. The mean for each summary scale is 50 points with standard deviation of 10 points. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
SF-36 Mental Component Score (MCS) Change at 1 Month
|
-1.84 units on a scale
Standard Deviation 15.41
|
4.96 units on a scale
Standard Deviation 1.80
|
SECONDARY outcome
Timeframe: Baseline to 1 monthThe Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) is a well-validated generic HRQOL questionnaire that generates two composite scores: the Physical Component Score (PCS) and Mental Component Score (MCS). The PCS aggregates items from Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, and Social Functioning. The MCS aggregates items from Role-Emotional, Mental Health, General Health, Vitality, and Social Functioning. The mean for each summary scale is 50 points with standard deviation of 10 points. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
SF-36 Physical Component Score (PCS) Change at 1 Month
|
12.31 units on a scale
Standard Deviation 11.72
|
11.95 units on a scale
Standard Deviation 11.40
|
SECONDARY outcome
Timeframe: Baseline to 1 monthThe Patient Health Questionnaire (PHQ-9) Depression Index is a well-established index of depression and has been validated in many patient populations. Its scores range from 0-27 with increasing scores representing increasing depression severity. Score categories represent depression severity and management recommendations: 0-4 - Minimal or no depression. Monitor; may not require treatment. 5-9 - Mild. Use clinical judgment (symptom duration, functional impairment) to determine necessity of treatment. 10-14 - Moderate. Use clinical judgment (symptom duration, functional impairment) to determine necessity of treatment. 15-19 - Moderately severe. Warrants active treatment with psychotherapy, medications, or combination. 20-27 - Severe. Warrants active treatment with psychotherapy, medications, or combination.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
PHQ-9 Depression Index Change at 1 Month
|
-3.5 units on a scale
Standard Deviation 6.0
|
-7.0 units on a scale
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Baseline to 1 monthThe Pittsburgh Sleep Quality Index (PSQI) is the most widely used global sleep assessment and has been studied in the renal transplant population. Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Traditionally, the items from the PSQI have been summed to create a total score to measure overall sleep quality.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
PSQI Total Score Change at 1 Month
|
-2.5 units on a scale
Standard Deviation 5.0
|
-1.0 units on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsThe Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. A 10 point decline in KCCQ scores has important prognostic significance in terms of survival.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Score Change at 3 Months
|
13.84 units on a scale
Standard Deviation 17.04
|
24.47 units on a scale
Standard Deviation 12.29
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsThe Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. A 10 point decline in KCCQ scores has important prognostic significance in terms of survival.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score Change at 3 Months
|
9.00 units on a scale
Standard Deviation 17.24
|
23.00 units on a scale
Standard Deviation 22.10
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsThe Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) is a well-validated generic HRQOL questionnaire that generates two composite scores: the Physical Component Score (PCS) and Mental Component Score (MCS). The PCS aggregates items from Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, and Social Functioning. The MCS aggregates items from Role-Emotional, Mental Health, General Health, Vitality, and Social Functioning. The mean for each summary scale is 50 points with standard deviation of 10 points. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
SF-36 Mental Component Score (MCS) Change at 3 Months
|
6.06 units on a scale
Standard Deviation 10.83
|
-0.40 units on a scale
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsThe Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) is a well-validated generic HRQOL questionnaire that generates two composite scores: the Physical Component Score (PCS) and Mental Component Score (MCS). The PCS aggregates items from Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, and Social Functioning. The MCS aggregates items from Role-Emotional, Mental Health, General Health, Vitality, and Social Functioning. The mean for each summary scale is 50 points with standard deviation of 10 points. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
SF-36 Physical Component Score (PCS) Change at 3 Months
|
16.25 units on a scale
Standard Deviation 8.50
|
12.90 units on a scale
Standard Deviation 10.61
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsThe Patient Health Questionnaire (PHQ-9) Depression Index is a well-established index of depression and has been validated in many patient populations. Its scoring ranges from 0-27 with increasing scores representing increasing depression severity. Score categories determine depression severity and recommended management: 0-4 - Minimal or none. Monitor; may not require treatment. 5-9 - Mild. Use clinical judgment (symptom duration, functional impairment) to determine necessity of treatment. 10-14 - Moderate. Use clinical judgment (symptom duration, functional impairment) to determine necessity of treatment. 15-19 - Moderately severe. Warrants active treatment with psychotherapy, medications, or combination. 20-27 - Severe. Warrants active treatment with psychotherapy, medications, or combination.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
PHQ-9 Depression Index Change at 3 Months
|
-1.00 units on a scale
Standard Deviation 5.00
|
-4.00 units on a scale
Standard Deviation 7.50
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsThe Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Traditionally, the items from the PSQI have been summed to create a total score to measure overall sleep quality.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
PSQI Total Score Change at 3 Months
|
-1.00 units on a scale
Standard Deviation 5.00
|
-4.00 units on a scale
Standard Deviation 8.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Daily while in hospital , 1 mo, & 3 mosHypokalemia (K \<3.0 milliequivalents (mEq)/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other (recorded as short description).
Outcome measures
| Measure |
Usual Care
n=10 Participants
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=8 Participants
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
Adverse Events
|
2.0 events
Standard Deviation 6.0
|
3.5 events
Standard Deviation 7.0
|
Adverse Events
Usual Care
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Protocolized Diuretic Strategy
Serious events: 1 serious events
Other events: 2 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Usual Care
n=10 participants at risk
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=9 participants at risk
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
Cardiac disorders
Cardiac arrhythmia
|
20.0%
2/10 • Number of events 4 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
11.1%
1/9 • Number of events 2 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
|
Cardiac disorders
Hospitalization
|
20.0%
2/10 • Number of events 3 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
0.00%
0/9 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
|
Musculoskeletal and connective tissue disorders
Hospitalization for non-cardiac cause
|
10.0%
1/10 • Number of events 1 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
0.00%
0/9 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
Other adverse events
| Measure |
Usual Care
n=10 participants at risk
Participants randomized to the Usual Care group (control arm) will receive escalating diuretics and medical therapy per HF guidelines published by the American College of Cardiology (ACC)/American Heart Association (AHA) and Heart Failure Society of America (HFSA), dosed in variable fashion at the discretion of the treating cardiologist.
|
Protocolized Diuretic Strategy
n=9 participants at risk
Participants randomized to the Protocolized Diuretic Strategy group will receive escalating diuretics according to an algorithm targeting a goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide). If UO is \< 3 L/day, diuretic regimen will be increased. If UO is 3-5 L/day, diuretic regimen will be continued at current doses. If UO is \> 5 L/day, diuretic regimen will be reduced.
|
|---|---|---|
|
Renal and urinary disorders
Hypokalemia
|
30.0%
3/10 • Number of events 4 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
11.1%
1/9 • Number of events 1 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
|
Renal and urinary disorders
Hyponatremia
|
40.0%
4/10 • Number of events 5 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
22.2%
2/9 • Number of events 2 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
|
Renal and urinary disorders
Hyperphosphatemia
|
20.0%
2/10 • Number of events 2 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
0.00%
0/9 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
|
Renal and urinary disorders
Worsening acute kidney injury
|
60.0%
6/10 • Number of events 9 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
11.1%
1/9 • Number of events 2 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
|
Renal and urinary disorders
Hypercalcemia
|
10.0%
1/10 • Number of events 1 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
11.1%
1/9 • Number of events 1 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
|
Renal and urinary disorders
Hypermagnesemia
|
10.0%
1/10 • Number of events 1 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
11.1%
1/9 • Number of events 1 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
|
Renal and urinary disorders
Hyperkalemia
|
10.0%
1/10 • Number of events 1 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
0.00%
0/9 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
|
Cardiac disorders
Chest pain
|
10.0%
1/10 • Number of events 2 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
0.00%
0/9 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
|
Cardiac disorders
Hypotension
|
10.0%
1/10 • Number of events 1 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
0.00%
0/9 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
|
General disorders
Fall
|
0.00%
0/10 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
11.1%
1/9 • Number of events 1 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
|
General disorders
Severe head/neck pain
|
10.0%
1/10 • Number of events 1 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
0.00%
0/9 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
|
General disorders
Leg and abdominal cramps
|
10.0%
1/10 • Number of events 1 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
0.00%
0/9 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Number of events 1 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
0.00%
0/9 • 3 months
Acute kidney injury, hypokalemia (K \<3.0 mEq/L), hypotension (systolic BP \<90 mmHg), hyponatremia (Na \<130 mEq/L), arrhythmias, cramps, and other were recorded. For each adverse event, diagnosis, date of onset, date of resolution, severity, whether it was unexpected, related to the intervention, serious adverse event (SAE), type of SAE, whether the blind was broken, and the outcome were recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place