Trial Outcomes & Findings for Effectiveness of Ultrafiltration in Treating People With Acute Decompensated Heart Failure and Cardiorenal Syndrome (The CARRESS Study) (NCT NCT00608491)
NCT ID: NCT00608491
Last Updated: 2013-06-24
Results Overview
COMPLETED
PHASE3
188 participants
Change from Baseline to Day 4
2013-06-24
Participant Flow
Participant milestones
| Measure |
Stepped Pharmacologic Care
Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes
|
Ultrafiltration
Participants will receive ultrafiltration
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
94
|
|
Overall Study
COMPLETED
|
73
|
72
|
|
Overall Study
NOT COMPLETED
|
21
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Ultrafiltration in Treating People With Acute Decompensated Heart Failure and Cardiorenal Syndrome (The CARRESS Study)
Baseline characteristics by cohort
| Measure |
Stepped Pharmacologic Care
n=94 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=94 Participants
Participants will receive ultrafiltration
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
52 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Age Continuous
|
67.1 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
68.9 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
68.0 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=94 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=92 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Serum Creatinine
|
-0.04 mg/dL
Standard Deviation 0.53
|
0.23 mg/dL
Standard Deviation 0.70
|
PRIMARY outcome
Timeframe: Change from Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=94 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=93 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Weight
|
-12.1 lbs
Standard Deviation 11.3
|
-12.6 lbs
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Change from Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=94 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=92 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Glomerular Filtration Rate
|
1.67 mL/min
Standard Deviation 10.94
|
0.93 mL/min
Standard Deviation 14.60
|
SECONDARY outcome
Timeframe: Change from Baseline to Day 7Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=94 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=92 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Serum Creatinine
|
-0.00 mg/dL
Standard Deviation 0.60
|
0.11 mg/dL
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Change from Baseline to Day 7Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=94 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=92 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Glomerular Filtration Rate
|
2.06 mL/min
Standard Deviation 9.32
|
1.82 mL/min
Standard Deviation 13.84
|
SECONDARY outcome
Timeframe: Change from Baseline to Day 1Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=90 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=88 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Changes in Weight
|
-3.4 lbs
Standard Deviation 5.2
|
-4.4 lbs
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Change from Baseline to Day 2Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=94 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=91 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Changes in Weight
|
-7.4 lbs
Standard Deviation 8.6
|
-8.8 lbs
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Change from Baseline to Day 3Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=88 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=86 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Weight
|
-10.8 lbs
Standard Deviation 10.5
|
-11.7 lbs
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Change from Baseline to Day 5Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=62 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=69 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Changes in Weight
|
-15.6 lbs
Standard Deviation 12.0
|
-14.3 lbs
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Change from Baseline to Day 6Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=51 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=59 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Weight
|
-16.5 lbs
Standard Deviation 15.3
|
-15.7 lbs
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Randomization through Day 1Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=94 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=93 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Cumulative Net Fluid Loss
|
1714.1 mL
Standard Deviation 1400.2
|
2193.6 mL
Standard Deviation 1554.9
|
SECONDARY outcome
Timeframe: Randomization through Day 2Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=92 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=93 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Cumulative Net Fluid Loss
|
3814.2 mL
Standard Deviation 2384.2
|
4705.8 mL
Standard Deviation 2626.9
|
SECONDARY outcome
Timeframe: Randomization through Day 3Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=89 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=90 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Cumulative Net Fluid Loss
|
5706.8 mL
Standard Deviation 3490.6
|
6257.1 mL
Standard Deviation 3519.7
|
SECONDARY outcome
Timeframe: Randomization through Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=79 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=81 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Cumulative Net Fluid Loss
|
7081.5 mL
Standard Deviation 4183.4
|
7443.0 mL
Standard Deviation 4328.7
|
SECONDARY outcome
Timeframe: Randomization through Day 5Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=63 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=69 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Cumulative Net Fluid Loss
|
8358.8 mL
Standard Deviation 5034.5
|
8308.4 mL
Standard Deviation 5178.1
|
SECONDARY outcome
Timeframe: Randomization through Day 6Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=53 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=55 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Cumulative Net Fluid Loss
|
9700.7 mL
Standard Deviation 6945.9
|
9822.1 mL
Standard Deviation 6001.7
|
SECONDARY outcome
Timeframe: Randomization through Day 7Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=40 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=47 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Cumulative Net Fluid Loss
|
11659.6 mL
Standard Deviation 9142.0
|
10595.1 mL
Standard Deviation 7097.4
|
SECONDARY outcome
Timeframe: Change from Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Scale range: -100 , +100 -100=worse, +100=better
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=88 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=83 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Dyspnea Visual Analog Scale
|
20.5 units on a scale
Standard Deviation 27.8
|
16.5 units on a scale
Standard Deviation 29.2
|
SECONDARY outcome
Timeframe: Change from Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Scale range: -100 , +100 -100=worse, +100=better Participants asked to mark their global well being on a 10 cm vertical line, with the top labeled "best you have ever felt" and the bottom labeled "worst you have ever felt".
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=87 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=81 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Global Visual Analog Scale
|
22.8 units on a scale
Standard Deviation 25.8
|
13.7 units on a scale
Standard Deviation 27.9
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Scale range: -100 , +100 -100=worse, +100=better
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=88 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=86 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Dyspnea Visual Analog Scale
|
22.8 units on a scale
Standard Deviation 27.6
|
19.4 units on a scale
Standard Deviation 31.4
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Scale range: -100 , +100 -100=worse, +100=better Participants asked to mark their global well being on a 10 cm vertical line, with the top labeled "best you have ever felt" and the bottom labeled "worst you have ever felt".
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=87 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=86 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Global Visual Analog Scale
|
25.8 units on a scale
Standard Deviation 30.2
|
16.9 units on a scale
Standard Deviation 29.0
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=92 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=89 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Furosemide-Equivalent Dose
|
2.2 mg
Standard Deviation 166.5
|
-20.6 mg
Standard Deviation 116.0
|
SECONDARY outcome
Timeframe: Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=94 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=92 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Sodium Level
|
0.00 mEq/L
Standard Deviation 3.60
|
-2.3 mEq/L
Standard Deviation 3.51
|
SECONDARY outcome
Timeframe: Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=94 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=92 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Potassium Level
|
-0.23 mEq/L
Standard Deviation 0.63
|
0.26 mEq/L
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=94 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=93 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Urea Nitrogen/Urea
|
5.68 mg/dL
Standard Deviation 18.29
|
12.54 mg/dL
Standard Deviation 24.81
|
SECONDARY outcome
Timeframe: Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=89 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=84 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Bicarbonate Level
|
3.29 mEq/L
Standard Deviation 3.82
|
-1.01 mEq/L
Standard Deviation 4.17
|
SECONDARY outcome
Timeframe: Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=89 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=93 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Hemoglobin Level
|
0.38 g/dL
Standard Deviation 0.76
|
-0.01 g/dL
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=94 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=92 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Sodium Level
|
-0.49 mEq/L
Standard Deviation 3.70
|
-2.02 mEq/L
Standard Deviation 4.11
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=94 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=92 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Potassium Level
|
-0.14 mEq/L
Standard Deviation 0.60
|
0.27 mEq/L
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=94 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=93 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Urea Nitrogen/Urea
|
7.23 mg/dL
Standard Deviation 20.69
|
13.81 mg/dL
Standard Deviation 23.91
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=89 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=84 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Bicarbonate Level
|
3.07 mEq/L
Standard Deviation 4.50
|
-0.70 mEq/L
Standard Deviation 5.03
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=89 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=93 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Hemoglobin Level
|
0.35 g/dL
Standard Deviation 0.94
|
-0.02 g/dL
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=85 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=81 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Cystatin C
|
0.14 mg/L
Standard Deviation 0.52
|
0.22 mg/L
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=85 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=80 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Uric Acid
|
1.06 mg/dL
Standard Deviation 1.44
|
-0.23 mg/dL
Standard Deviation 1.67
|
SECONDARY outcome
Timeframe: Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=84 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=79 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood N- Terminal Pro- BNP
|
-978.61 pg/mL
Standard Deviation 2902.06
|
-814.45 pg/mL
Standard Deviation 9238.91
|
SECONDARY outcome
Timeframe: Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=85 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=81 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Plasma Renin Activity
|
5.78 ng/mL/hr
Standard Deviation 45.65
|
12.67 ng/mL/hr
Standard Deviation 31.32
|
SECONDARY outcome
Timeframe: Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=84 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=81 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood High Sensitivity Troponin I
|
47.38 pg/mL
Standard Deviation 369.85
|
-38.95 pg/mL
Standard Deviation 1027.37
|
SECONDARY outcome
Timeframe: Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=86 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=81 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Aldosterone
|
-109.13 pg/mL
Standard Deviation 489.50
|
-3.07 pg/mL
Standard Deviation 485.40
|
SECONDARY outcome
Timeframe: Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=86 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=81 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Procollagen III N-terminal Propepide
|
0.22 ug/L
Standard Deviation 4.69
|
-0.64 ug/L
Standard Deviation 4.02
|
SECONDARY outcome
Timeframe: Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=83 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=78 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Endothelin-1
|
-0.76 pg/mL
Standard Deviation 1.70
|
-1.13 pg/mL
Standard Deviation 3.20
|
SECONDARY outcome
Timeframe: Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=85 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=81 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood High Sensitivity C-Reactive Protein
|
-1.71 mg/L
Standard Deviation 46.14
|
1.89 mg/L
Standard Deviation 28.60
|
SECONDARY outcome
Timeframe: Baseline to Day 4Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=83 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=76 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Carboxy-terminal Telopeptide of Collagen Type I
|
7.63 ug/L
Standard Deviation 11.93
|
9.07 ug/L
Standard Deviation 13.46
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=86 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=83 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Cystatin C
|
0.12 mg/L
Standard Deviation 0.48
|
0.09 mg/L
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=86 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=82 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Uric Acid
|
1.10 mg/dL
Standard Deviation 1.85
|
-0.15 mg/dL
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=86 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=83 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood N Terminal Pro-Natriuretic Peptide
|
-1071.88 pg/mL
Standard Deviation 3309.45
|
-740.82 pg/mL
Standard Deviation 8604.86
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=86 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=83 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Plasma Renin Activity
|
2.58 ng/mL/hr
Standard Deviation 40.70
|
11.40 ng/mL/hr
Standard Deviation 32.75
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=86 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=83 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood High Sensitivity Troponin I
|
37.28 pg/mL
Standard Deviation 350.45
|
-37.16 pg/mL
Standard Deviation 1231.12
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=87 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=83 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Aldosterone
|
-74.26 pg/mL
Standard Deviation 507.96
|
68.13 pg/mL
Standard Deviation 624.35
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=87 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=83 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Procollagen III N-terminal Propepide
|
-0.07 ug/L
Standard Deviation 5.90
|
-0.93 ug/L
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=85 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=83 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Endothelin-1
|
-0.69 pg/mL
Standard Deviation 1.85
|
-1.24 pg/mL
Standard Deviation 3.22
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=85 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=83 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Carboxy-terminal Telopeptide of Collagen Type I
|
10.21 ug/L
Standard Deviation 15.79
|
10.54 ug/L
Standard Deviation 15.04
|
SECONDARY outcome
Timeframe: Baseline to Day 7/DischargePopulation: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=86 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=83 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood High Sensitivity C-Reactive Protein
|
-6.39 mg/L
Standard Deviation 48.56
|
2.18 mg/L
Standard Deviation 37.72
|
SECONDARY outcome
Timeframe: Baseline to Day 30Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=73 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=68 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Weight Change
|
-15.9 lbs
Standard Deviation 22.4
|
-13.4 lbs
Standard Deviation 21.0
|
SECONDARY outcome
Timeframe: Baseline to Day 30Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=78 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=74 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Furosemide-Equivalent Dose
|
9.8 mg
Standard Deviation 188.3
|
27.3 mg
Standard Deviation 120.1
|
SECONDARY outcome
Timeframe: Baseline to Day 30Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=75 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=70 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Creatinine Change
|
-0.25 mg/dL
Standard Deviation 0.68
|
-0.12 mg/dL
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Baseline to Day 30Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=75 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=70 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Glomerular Filtration Rate Change
|
7.95 mL/min
Standard Deviation 11.85
|
6.07 mL/min
Standard Deviation 16.13
|
SECONDARY outcome
Timeframe: Baseline to Day 60Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=66 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=63 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Weight Change
|
-17.2 lbs
Standard Deviation 21.1
|
-15.4 lbs
Standard Deviation 23.1
|
SECONDARY outcome
Timeframe: Baseline to Day 60Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=73 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=72 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Furosemide-Equivalent Dose
|
-12.4 mg
Standard Deviation 122.5
|
8.8 mg
Standard Deviation 128.5
|
SECONDARY outcome
Timeframe: Baseline to Day 60Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Core laboratory when available. If not available, local laboratory results were used.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=67 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=70 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Best Available Serum Creatinine Change
|
-0.28 mg/dL
Standard Deviation 0.61
|
-0.12 mg/dL
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Baseline to Day 60Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Core laboratory when available. If not available, local laboratory results were used.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=67 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=70 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Best Available Glomerular Filtration Rate Change
|
8.86 mL/min
Standard Deviation 13.26
|
5.63 mL/min
Standard Deviation 16.49
|
SECONDARY outcome
Timeframe: Baseline to Day 60Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=56 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=54 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Uric Acid
|
-0.31 mg/dL
Standard Deviation 2.28
|
-0.54 mg/dL
Standard Deviation 2.60
|
SECONDARY outcome
Timeframe: Baseline to Day 60Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=56 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=55 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Cystatin C
|
-0.18 mg/L
Standard Deviation 0.48
|
-0.03 mg/L
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Baseline to Day 60Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=56 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=55 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood N Terminal Pro - B Natriuretic Peptides
|
-490.56 pg/mL
Standard Deviation 5638.86
|
-937.69 pg/mL
Standard Deviation 7389.14
|
SECONDARY outcome
Timeframe: Baseline to Day 60Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=56 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=55 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Plasma Renin Activity
|
-2.18 ng/mL/hr
Standard Deviation 41.12
|
0.54 ng/mL/hr
Standard Deviation 20.48
|
SECONDARY outcome
Timeframe: Baseline to Day 60Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=56 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=55 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood High Sensitivity Troponin I
|
-17.48 pg/mL
Standard Deviation 106.70
|
-73.58 pg/mL
Standard Deviation 511.98
|
SECONDARY outcome
Timeframe: Baseline to Day 60Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=57 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=55 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Aldosterone
|
-6.91 pg/mL
Standard Deviation 672.21
|
40.35 pg/mL
Standard Deviation 471.50
|
SECONDARY outcome
Timeframe: Baseline to Day 60Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=57 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=56 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Procollagen III N-terminal Propepide
|
0.75 ug/L
Standard Deviation 5.25
|
0.58 ug/L
Standard Deviation 6.02
|
SECONDARY outcome
Timeframe: Baseline to Day 60Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=56 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=55 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Endothelin-1
|
-0.82 pg/mL
Standard Deviation 1.58
|
-1.32 pg/mL
Standard Deviation 3.98
|
SECONDARY outcome
Timeframe: Baseline to Day 60Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=56 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=55 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood High Sensitivity C-Reactive Protein
|
-13.62 mg/L
Standard Deviation 59.58
|
1.99 mg/L
Standard Deviation 44.92
|
SECONDARY outcome
Timeframe: Baseline to Day 60Population: Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Outcome measures
| Measure |
Stepped Pharmacologic Care
n=56 Participants
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=55 Participants
Participants will receive ultrafiltration
|
|---|---|---|
|
Change in Blood Carboxy-terminal Telopeptide of Collagen Type I
|
2.24 ug/L
Standard Deviation 13.44
|
4.57 ug/L
Standard Deviation 27.84
|
Adverse Events
Stepped Pharmacologic Care
Ultrafiltration
Serious adverse events
| Measure |
Stepped Pharmacologic Care
n=94 participants at risk
Participants will receive stepped pharmacologic care
|
Ultrafiltration
n=94 participants at risk
Participants will receive ultrafiltration
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
5/94
|
6.4%
6/94
|
|
Blood and lymphatic system disorders
Heparin-Induced Thrombocytopenia
|
0.00%
0/94
|
1.1%
1/94
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/94
|
1.1%
1/94
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/94
|
1.1%
1/94
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/94
|
1.1%
1/94
|
|
Cardiac disorders
Angina Pectoris
|
1.1%
1/94
|
1.1%
1/94
|
|
Cardiac disorders
Atrial Fibrillation
|
1.1%
1/94
|
2.1%
2/94
|
|
Cardiac disorders
Cardiac Failure
|
18.1%
17/94
|
17.0%
16/94
|
|
Cardiac disorders
Cardiac Failure Acute
|
12.8%
12/94
|
16.0%
15/94
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.00%
0/94
|
2.1%
2/94
|
|
Cardiac disorders
Pulseless Electrical Activity
|
1.1%
1/94
|
0.00%
0/94
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/94
|
1.1%
1/94
|
|
Cardiac disorders
Ventricular Fibrillation
|
1.1%
1/94
|
0.00%
0/94
|
|
Cardiac disorders
Ventricular Tachycardia
|
1.1%
1/94
|
0.00%
0/94
|
|
Renal and urinary disorders
Haematuria
|
1.1%
1/94
|
2.1%
2/94
|
|
Renal and urinary disorders
Renal Failure
|
11.7%
11/94
|
10.6%
10/94
|
|
Renal and urinary disorders
Renal Failure Acute
|
3.2%
3/94
|
6.4%
6/94
|
|
Renal and urinary disorders
Renal Failure Chronic
|
2.1%
2/94
|
0.00%
0/94
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/94
|
1.1%
1/94
|
|
Renal and urinary disorders
Renal Tubular Necrosis
|
0.00%
0/94
|
1.1%
1/94
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.00%
0/94
|
1.1%
1/94
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place