Trial Outcomes & Findings for Oral Metolazone and Intermittent Intravenous Furosemide Versus Continuous Infusion Furosemide in Acute Heart Failure (NCT NCT00904488)
NCT ID: NCT00904488
Last Updated: 2018-03-13
Results Overview
Net fluid output = fluid output during 24-48 hours after randomization - fluid intake during 24-48 hours after randomization. A negative value means that daily fluid intake was less than the daily fluid output.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
24-48 hours
Results posted on
2018-03-13
Participant Flow
Participant milestones
| Measure |
Furosemide Dose Escalation
Furosemide dose escalation given either as IV bolus (2-2.5 x current dose) or continuous infusion (2-2.5 x current dose administered over previous 24 hours)
|
IVB Loop and PO Thiazide Diuretic
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BNP was not measured on admission as part of routine clinical care in all subjects.
Baseline characteristics by cohort
| Measure |
Furosemide Dose Escalation
n=5 Participants
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
|
IVB Loop and PO Thiazide Diuretic
n=6 Participants
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 16.2 • n=6 Participants
|
56.6 years
STANDARD_DEVIATION 15.3 • n=11 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=11 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=11 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=11 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
11 Participants
n=11 Participants
|
|
Baseline Ejection Fraction (EF) (%)
Mild (55-60%)
|
2 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=11 Participants
|
|
Baseline Ejection Fraction (EF) (%)
Moderate (20-40%)
|
1 Participants
n=5 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=11 Participants
|
|
Baseline Ejection Fraction (EF) (%)
Severe (5-15%)
|
2 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=11 Participants
|
|
Chief Complaints
Shortness of Breath (SOB)
|
2 participants
n=5 Participants
|
2 participants
n=6 Participants
|
3 participants
n=11 Participants
|
|
Chief Complaints
Weight Gain
|
0 participants
n=5 Participants
|
1 participants
n=6 Participants
|
1 participants
n=11 Participants
|
|
Chief Complaints
Fluid Overload
|
1 participants
n=5 Participants
|
2 participants
n=6 Participants
|
2 participants
n=11 Participants
|
|
Afib on Admission
Present
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Afib on Admission
Absent
|
3 Participants
n=5 Participants
|
5 Participants
n=6 Participants
|
8 Participants
n=11 Participants
|
|
Afib on Admission
Not reported
|
2 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=11 Participants
|
|
New York Heart Association (NYHA) Class on Admission
Class I
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
New York Heart Association (NYHA) Class on Admission
Class II
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
New York Heart Association (NYHA) Class on Admission
Class III
|
0 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=11 Participants
|
|
New York Heart Association (NYHA) Class on Admission
Class IV
|
1 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=11 Participants
|
|
New York Heart Association (NYHA) Class on Admission
Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=11 Participants
|
|
Comorbidities
Anemia
|
2 participants
n=5 Participants
|
0 participants
n=6 Participants
|
2 participants
n=11 Participants
|
|
Comorbidities
Coronary artery disease (CAD)
|
1 participants
n=5 Participants
|
3 participants
n=6 Participants
|
4 participants
n=11 Participants
|
|
Comorbidities
Chronic obstructive pulmonary disease (COPD)
|
0 participants
n=5 Participants
|
2 participants
n=6 Participants
|
2 participants
n=11 Participants
|
|
Comorbidities
Cerebrovascular accident (CVA)
|
1 participants
n=5 Participants
|
2 participants
n=6 Participants
|
3 participants
n=11 Participants
|
|
Comorbidities
Diabetes
|
4 participants
n=5 Participants
|
3 participants
n=6 Participants
|
7 participants
n=11 Participants
|
|
Comorbidities
Dyslipidemia
|
4 participants
n=5 Participants
|
2 participants
n=6 Participants
|
6 participants
n=11 Participants
|
|
Comorbidities
Gastroesophageal reflux disease (GERD)
|
1 participants
n=5 Participants
|
0 participants
n=6 Participants
|
1 participants
n=11 Participants
|
|
Comorbidities
Gout
|
1 participants
n=5 Participants
|
1 participants
n=6 Participants
|
2 participants
n=11 Participants
|
|
Comorbidities
Human immunodeficiency virus (HIV)
|
1 participants
n=5 Participants
|
0 participants
n=6 Participants
|
1 participants
n=11 Participants
|
|
Comorbidities
Myocardial infarction (MI)
|
1 participants
n=5 Participants
|
1 participants
n=6 Participants
|
2 participants
n=11 Participants
|
|
Comorbidities
Hypertension
|
4 participants
n=5 Participants
|
4 participants
n=6 Participants
|
8 participants
n=11 Participants
|
|
Comorbidities
Obesity
|
2 participants
n=5 Participants
|
1 participants
n=6 Participants
|
3 participants
n=11 Participants
|
|
Comorbidities
Obstructive Sleep Apnea
|
2 participants
n=5 Participants
|
2 participants
n=6 Participants
|
4 participants
n=11 Participants
|
|
Medication
Beta Blocker
|
4 participants
n=5 Participants
|
4 participants
n=6 Participants
|
8 participants
n=11 Participants
|
|
Medication
Angiotensin-converting-enzyme inhibitor
|
4 participants
n=5 Participants
|
6 participants
n=6 Participants
|
10 participants
n=11 Participants
|
|
Medication
Angiotensin Receptor Blockers
|
0 participants
n=5 Participants
|
0 participants
n=6 Participants
|
0 participants
n=11 Participants
|
|
Medication
Loop Diuretic
|
4 participants
n=5 Participants
|
5 participants
n=6 Participants
|
9 participants
n=11 Participants
|
|
Medication
Aldosterone Antagonist
|
0 participants
n=5 Participants
|
1 participants
n=6 Participants
|
1 participants
n=11 Participants
|
|
Medication
Digoxin
|
2 participants
n=5 Participants
|
0 participants
n=6 Participants
|
2 participants
n=11 Participants
|
|
Medication
Calcium Channel Blocker
|
2 participants
n=5 Participants
|
1 participants
n=6 Participants
|
3 participants
n=11 Participants
|
|
Medication
Isosorbide Dinitrate
|
1 participants
n=5 Participants
|
1 participants
n=6 Participants
|
2 participants
n=11 Participants
|
|
Medication
Hydralazine
|
4 participants
n=5 Participants
|
1 participants
n=6 Participants
|
5 participants
n=11 Participants
|
|
Medication
Statin
|
5 participants
n=5 Participants
|
4 participants
n=6 Participants
|
9 participants
n=11 Participants
|
|
Medication
Anticoagulant
|
2 participants
n=5 Participants
|
3 participants
n=6 Participants
|
5 participants
n=11 Participants
|
|
Medication
Aspirin
|
2 participants
n=5 Participants
|
5 participants
n=6 Participants
|
7 participants
n=11 Participants
|
|
Medication
Potassium supplement
|
1 participants
n=5 Participants
|
3 participants
n=6 Participants
|
4 participants
n=11 Participants
|
|
Brain Natriuretic Peptide (BNP) at admission
|
6800.75 pg/ml
STANDARD_DEVIATION 10330.95 • n=4 Participants • BNP was not measured on admission as part of routine clinical care in all subjects.
|
5401.33 pg/ml
STANDARD_DEVIATION 4183.06 • n=3 Participants • BNP was not measured on admission as part of routine clinical care in all subjects.
|
6201.00 pg/ml
STANDARD_DEVIATION 7313.54 • n=7 Participants • BNP was not measured on admission as part of routine clinical care in all subjects.
|
PRIMARY outcome
Timeframe: 24-48 hoursNet fluid output = fluid output during 24-48 hours after randomization - fluid intake during 24-48 hours after randomization. A negative value means that daily fluid intake was less than the daily fluid output.
Outcome measures
| Measure |
Furosemide Dose Escalation
n=5 Participants
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
|
IVB Loop and PO Thiazide Diuretic
n=6 Participants
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
|
|---|---|---|
|
Daily Net Fluid Output on Day 2 (24-48 Hours After Randomization)
|
-1454.60 mL/day
Standard Deviation 1339.53
|
-1322.83 mL/day
Standard Deviation 1738.30
|
SECONDARY outcome
Timeframe: 0-24, 48-72, 72-96 hrsPopulation: If diuretic therapy is changed to the oral route before a scheduled efficacy endpoint is to be measured (e.g.72 or 96 hour net output), then that endpoint will not be obtained.
Daily net fluid output = daily fluid output - daily intake. A negative value means that daily fluid intake was less than the daily fluid output.
Outcome measures
| Measure |
Furosemide Dose Escalation
n=5 Participants
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
|
IVB Loop and PO Thiazide Diuretic
n=6 Participants
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
|
|---|---|---|
|
Daily Net Fluid Output on Days 1, 3, and 4
0-24 hr
|
-2226.74 ml/day
Standard Deviation 2063.63
|
-3076.67 ml/day
Standard Deviation 1555.63
|
|
Daily Net Fluid Output on Days 1, 3, and 4
48-72 hr
|
-2108.00 ml/day
Standard Deviation 2187.05
|
-409.74 ml/day
Standard Deviation 1208.98
|
|
Daily Net Fluid Output on Days 1, 3, and 4
72-96 hr
|
-2433.33 ml/day
Standard Deviation 1374.38
|
-705.33 ml/day
Standard Deviation 157.39
|
SECONDARY outcome
Timeframe: 0-24, 24-48, 48-72, 72-96 hrsPopulation: Data were not collected at all time points for all subjects, and were only analyzed when available. Data not analyzed on days when diuretics were held or discontinued.
Outcome measures
| Measure |
Furosemide Dose Escalation
n=5 Participants
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
|
IVB Loop and PO Thiazide Diuretic
n=6 Participants
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
|
|---|---|---|
|
Daily Urine Output (mL Urine Out Per mg Furosemide (IV Equivalent) Received)
0-24 hr
|
29.35 ml/mg furosemide received
Standard Deviation 21.01
|
17.35 ml/mg furosemide received
Standard Deviation 7.11
|
|
Daily Urine Output (mL Urine Out Per mg Furosemide (IV Equivalent) Received)
24-48 hr
|
8.28 ml/mg furosemide received
Standard Deviation 4.59
|
21.88 ml/mg furosemide received
Standard Deviation 14.39
|
|
Daily Urine Output (mL Urine Out Per mg Furosemide (IV Equivalent) Received)
48-72 hr
|
25.84 ml/mg furosemide received
Standard Deviation 20.05
|
25.52 ml/mg furosemide received
Standard Deviation 14.84
|
|
Daily Urine Output (mL Urine Out Per mg Furosemide (IV Equivalent) Received)
72-96 hr
|
43.94 ml/mg furosemide received
Standard Deviation 28.12
|
—
|
SECONDARY outcome
Timeframe: Baseline (Dry), Baseline, 0-24, 24-48, 48-72, 72-96 hrsPopulation: Data were not collected for all subjects at all time points, and were only analyzed when available
Outcome measures
| Measure |
Furosemide Dose Escalation
n=5 Participants
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
|
IVB Loop and PO Thiazide Diuretic
n=6 Participants
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
|
|---|---|---|
|
Daily Weight
Baseline
|
120.84 Kg
Standard Deviation 75.25
|
102.57 Kg
Standard Deviation 33.57
|
|
Daily Weight
Baseline (Dry)
|
82.35 Kg
Standard Deviation 40.87
|
100.82 Kg
Standard Deviation 49.35
|
|
Daily Weight
0-24 hr
|
154.23 Kg
Standard Deviation 103.30
|
101.07 Kg
Standard Deviation 32.88
|
|
Daily Weight
24-48 hr
|
129.73 Kg
Standard Deviation 91.46
|
99.08 Kg
Standard Deviation 32.93
|
|
Daily Weight
48-72 hr
|
135.07 Kg
Standard Deviation 101.31
|
106.70 Kg
Standard Deviation 52.18
|
|
Daily Weight
72-96 hr
|
172.10 Kg
Standard Deviation 107.71
|
86.87 Kg
Standard Deviation 48.17
|
SECONDARY outcome
Timeframe: Baseline, 24, 48, 72, 96 hrsPopulation: Data were not collected at all time points, and were only analyzed when available.
Scale range: 1-5 Which of the following best describes your overall health state today? 1. = markedly worse 2. = worse 3. = neither better nor worse 4. = better 5. = markedly better
Outcome measures
| Measure |
Furosemide Dose Escalation
n=5 Participants
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
|
IVB Loop and PO Thiazide Diuretic
n=6 Participants
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
|
|---|---|---|
|
Patient Global Assessment Scale
Baseline
|
3.25 units on a scale
Standard Deviation 1.67
|
3.67 units on a scale
Standard Deviation 2.23
|
|
Patient Global Assessment Scale
24 hr
|
4.2 units on a scale
Standard Deviation 0.45
|
4.25 units on a scale
Standard Deviation 2.23
|
|
Patient Global Assessment Scale
48 hr
|
3.8 units on a scale
Standard Deviation 1.1
|
3.6 units on a scale
Standard Deviation 1.67
|
|
Patient Global Assessment Scale
72 hr
|
4.67 units on a scale
Standard Deviation 2.59
|
3.75 units on a scale
Standard Deviation 1.97
|
|
Patient Global Assessment Scale
96 hr
|
4 units on a scale
Standard Deviation 2.19
|
4 units on a scale
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: Baseline, 24, 48, 72, 96 hoursPopulation: Data were not collected at all time points, and were only analyzed when available.
Scale range: 1-5 Which of the following best describes the patient's overall health state today? 1. = markedly worse 2. = worse 3. = neither better nor worse 4. = better 5. = markedly better
Outcome measures
| Measure |
Furosemide Dose Escalation
n=5 Participants
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
|
IVB Loop and PO Thiazide Diuretic
n=6 Participants
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
|
|---|---|---|
|
Physician Global Assessment Scale
Baseline
|
2.67 units on a scale
Standard Deviation 1.67
|
2 units on a scale
Standard Deviation 1.21
|
|
Physician Global Assessment Scale
24 hr
|
4.25 units on a scale
Standard Deviation 1.95
|
4 units on a scale
Standard Deviation 2.16
|
|
Physician Global Assessment Scale
48 hr
|
4 units on a scale
Standard Deviation 1.92
|
4 units on a scale
Standard Deviation 1.63
|
|
Physician Global Assessment Scale
72 hr
|
4.5 units on a scale
Standard Deviation 2.49
|
3.75 units on a scale
Standard Deviation 1.97
|
|
Physician Global Assessment Scale
96 hr
|
4 units on a scale
Standard Deviation 2.19
|
3.67 units on a scale
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: 0-96 hoursPatients will be considered a treatment failure if they require additional diuretic (including crossover to the alternative study arm) or require IV vasoactive drug therapy (e.g. vasodilators including nitroglycerin or inotropes) as deemed appropriate/necessary by their medical team.
Outcome measures
| Measure |
Furosemide Dose Escalation
n=5 Participants
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
|
IVB Loop and PO Thiazide Diuretic
n=6 Participants
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
|
|---|---|---|
|
Need for Additional or Alternative Diuretic (Crossover) or Other Vasoactive Therapy (Study Failure)
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 0-96 hoursPopulation: Weight was not collected in all subjects every day.
Outcome measures
| Measure |
Furosemide Dose Escalation
n=4 Participants
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
|
IVB Loop and PO Thiazide Diuretic
n=6 Participants
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
|
|---|---|---|
|
Time to Return to Baseline Weight
|
1.5 Days
Standard Deviation 1.1
|
1.5 Days
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Assessed till hospital discharge, an average of 1 week (longest 29 days)Population: Data not available in all subjects.
Outcome measures
| Measure |
Furosemide Dose Escalation
n=4 Participants
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
|
IVB Loop and PO Thiazide Diuretic
n=4 Participants
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
|
|---|---|---|
|
Length of Hospitalization
|
4.75 Days
Standard Deviation 1.71
|
11.25 Days
Standard Deviation 10.93
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Furosemide Dose Escalation
n=5 Participants
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
|
IVB Loop and PO Thiazide Diuretic
n=6 Participants
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
|
|---|---|---|
|
30-day All-cause Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 30-day follow up data (except for mortality) were not collected in 2 participants
Outcome measures
| Measure |
Furosemide Dose Escalation
n=4 Participants
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
|
IVB Loop and PO Thiazide Diuretic
n=5 Participants
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
|
|---|---|---|
|
Rehospitalization at 30 Days
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 30-day follow up data (except for mortality) were not collected in 2 participants
Outcome measures
| Measure |
Furosemide Dose Escalation
n=4 Participants
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
|
IVB Loop and PO Thiazide Diuretic
n=5 Participants
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
|
|---|---|---|
|
Unscheduled Heart Failure Visits to Emergency Department or Outpatient Clinic
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, 24, 48, 72, 96 hoursOutcome measures
| Measure |
Furosemide Dose Escalation
n=5 Participants
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
|
IVB Loop and PO Thiazide Diuretic
n=6 Participants
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
|
|---|---|---|
|
Blood Urea Nitrogen (BUN)
Baseline
|
31.20 mg/dL
Standard Deviation 11.05
|
29.83 mg/dL
Standard Deviation 16.82
|
|
Blood Urea Nitrogen (BUN)
24 hr
|
28.00 mg/dL
Standard Deviation 9.35
|
27.67 mg/dL
Standard Deviation 17.18
|
|
Blood Urea Nitrogen (BUN)
48 hr
|
30.80 mg/dL
Standard Deviation 11.45
|
33.17 mg/dL
Standard Deviation 16.92
|
|
Blood Urea Nitrogen (BUN)
72 hr
|
29.00 mg/dL
Standard Deviation 12.08
|
42.00 mg/dL
Standard Deviation 20.70
|
|
Blood Urea Nitrogen (BUN)
96 hr
|
38.60 mg/dL
Standard Deviation 19.63
|
42.67 mg/dL
Standard Deviation 20.63
|
Adverse Events
Furosemide Dose Escalation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
IVB Loop and PO Thiazide Diuretic
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Furosemide Dose Escalation
n=5 participants at risk
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
|
IVB Loop and PO Thiazide Diuretic
n=6 participants at risk
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
|
|---|---|---|
|
Cardiac disorders
critically low potassium (< 3.5 mmol/L) while receiving study therapy
|
0.00%
0/5 • Changes in labs and vitals were collected for 96 hours after randomization All-cause mortality were collected for 30 days after randomization
* Total number of times antihypertensive doses are held due to low blood pressure * Number of hypotensive episodes defined as systolic blood pressure below 85 mmHg or greater than 10 mmHg below baseline (whichever is greater) * Number of critically low potassium (\< 3.5 mmol/L) and magnesium (\< 1.6 mg/dL) concentrations while receiving study therapy
|
16.7%
1/6 • Number of events 1 • Changes in labs and vitals were collected for 96 hours after randomization All-cause mortality were collected for 30 days after randomization
* Total number of times antihypertensive doses are held due to low blood pressure * Number of hypotensive episodes defined as systolic blood pressure below 85 mmHg or greater than 10 mmHg below baseline (whichever is greater) * Number of critically low potassium (\< 3.5 mmol/L) and magnesium (\< 1.6 mg/dL) concentrations while receiving study therapy
|
|
Cardiac disorders
critically low magnesium (< 1.6 mg/dL) while receiving study therapy
|
0.00%
0/5 • Changes in labs and vitals were collected for 96 hours after randomization All-cause mortality were collected for 30 days after randomization
* Total number of times antihypertensive doses are held due to low blood pressure * Number of hypotensive episodes defined as systolic blood pressure below 85 mmHg or greater than 10 mmHg below baseline (whichever is greater) * Number of critically low potassium (\< 3.5 mmol/L) and magnesium (\< 1.6 mg/dL) concentrations while receiving study therapy
|
16.7%
1/6 • Number of events 1 • Changes in labs and vitals were collected for 96 hours after randomization All-cause mortality were collected for 30 days after randomization
* Total number of times antihypertensive doses are held due to low blood pressure * Number of hypotensive episodes defined as systolic blood pressure below 85 mmHg or greater than 10 mmHg below baseline (whichever is greater) * Number of critically low potassium (\< 3.5 mmol/L) and magnesium (\< 1.6 mg/dL) concentrations while receiving study therapy
|
|
Cardiac disorders
Hypotension
|
40.0%
2/5 • Number of events 8 • Changes in labs and vitals were collected for 96 hours after randomization All-cause mortality were collected for 30 days after randomization
* Total number of times antihypertensive doses are held due to low blood pressure * Number of hypotensive episodes defined as systolic blood pressure below 85 mmHg or greater than 10 mmHg below baseline (whichever is greater) * Number of critically low potassium (\< 3.5 mmol/L) and magnesium (\< 1.6 mg/dL) concentrations while receiving study therapy
|
100.0%
6/6 • Number of events 32 • Changes in labs and vitals were collected for 96 hours after randomization All-cause mortality were collected for 30 days after randomization
* Total number of times antihypertensive doses are held due to low blood pressure * Number of hypotensive episodes defined as systolic blood pressure below 85 mmHg or greater than 10 mmHg below baseline (whichever is greater) * Number of critically low potassium (\< 3.5 mmol/L) and magnesium (\< 1.6 mg/dL) concentrations while receiving study therapy
|
|
Cardiac disorders
Hypotension resulting in holding antihypertensive doses
|
0.00%
0/5 • Changes in labs and vitals were collected for 96 hours after randomization All-cause mortality were collected for 30 days after randomization
* Total number of times antihypertensive doses are held due to low blood pressure * Number of hypotensive episodes defined as systolic blood pressure below 85 mmHg or greater than 10 mmHg below baseline (whichever is greater) * Number of critically low potassium (\< 3.5 mmol/L) and magnesium (\< 1.6 mg/dL) concentrations while receiving study therapy
|
16.7%
1/6 • Number of events 8 • Changes in labs and vitals were collected for 96 hours after randomization All-cause mortality were collected for 30 days after randomization
* Total number of times antihypertensive doses are held due to low blood pressure * Number of hypotensive episodes defined as systolic blood pressure below 85 mmHg or greater than 10 mmHg below baseline (whichever is greater) * Number of critically low potassium (\< 3.5 mmol/L) and magnesium (\< 1.6 mg/dL) concentrations while receiving study therapy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place