Effectiveness of Ultrafiltration in Treating People With... | NCT00608491

ID	Type	Link
U01HL084904-04	U.S. NIH Grant/Contract	View source
U01HL084904	U.S. NIH Grant/Contract	View source
522

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH
Nuwellis, Inc.	INDUSTRY

Label	Type	Description	Intervention Names
Stepped pharmacologic care	Active Comparator	Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes.	Drug: Stepped pharmacologic care
Ultrafiltration	Experimental	All loop diuretics will be discontinued. Treatment will involve slow continuous ultrafiltration until an optimal volume status has been achieved. Ultrafiltration therapy will be initiated after the placement of appropriate intravenous access and will continue until the participant's signs and symptoms of congestion have been optimized. Fluid status will be managed exclusively by ultrafiltration using the Aquadex system 100 (CHF Solutions, Inc.) according to the manufacturer's specifications. The use of vasodilators or inotropic agents will be prohibited unless deemed necessary for rescue therapy.	Device: Ultrafiltration

Name	Type	Description	Arm Group Labels	Other Names
Stepped pharmacologic care	Drug	Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes.

Measure	Description	Time Frame
Change in Serum Creatinine		Change from Baseline to Day 4
Change in Weight		Change from Baseline to Day 4

Measure	Description	Time Frame
Change in Glomerular Filtration Rate		Change from Baseline to Day 4
Change in Serum Creatinine		Change from Baseline to Day 7
Change in Glomerular Filtration Rate

Name	Affiliation	Role
Kerry L. Lee, PhD	Duke Clinical Research Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Arizona		Phoenix	Arizona	85054	United States
Morehouse School of Medicine

PubMed Identifier	Type	Citation	Retractions
23131078	Result	Bart BA, Goldsmith SR, Lee KL, Givertz MM, O'Connor CM, Bull DA, Redfield MM, Deswal A, Rouleau JL, LeWinter MM, Ofili EO, Stevenson LW, Semigran MJ, Felker GM, Chen HH, Hernandez AF, Anstrom KJ, McNulty SE, Velazquez EJ, Ibarra JC, Mascette AM, Braunwald E; Heart Failure Clinical Research Network. Ultrafiltration in decompensated heart failure with cardiorenal syndrome. N Engl J Med. 2012 Dec 13;367(24):2296-304. doi: 10.1056/NEJMoa1210357. Epub 2012 Nov 6.
31163974

ID	Title	Description
FG000	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
FG001	Ultrafiltration

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Serum Creatinine

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mg/dL

Change from Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG00094 OG00192

Title

Denominators

Categories

Title	Measurements
	OG000-0.04± 0.53 OG0010.23± 0.70

Secondary

Change in Glomerular Filtration Rate

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mL/min

Change from Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Serum Creatinine

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mg/dL

Change from Baseline to Day 7

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Glomerular Filtration Rate

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mL/min

Change from Baseline to Day 7

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Changes in Weight

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

lbs

Change from Baseline to Day 1

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Changes in Weight

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

lbs

Change from Baseline to Day 2

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Weight

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

lbs

Change from Baseline to Day 3

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Changes in Weight

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

lbs

Change from Baseline to Day 5

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Weight

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

lbs

Change from Baseline to Day 6

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Cumulative Net Fluid Loss

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

Randomization through Day 1

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Cumulative Net Fluid Loss

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

Randomization through Day 2

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Primary

Change in Weight

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

lbs

Change from Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Cumulative Net Fluid Loss

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

Randomization through Day 3

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Cumulative Net Fluid Loss

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

Randomization through Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Cumulative Net Fluid Loss

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

Randomization through Day 5

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Cumulative Net Fluid Loss

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

Randomization through Day 6

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Cumulative Net Fluid Loss

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

Randomization through Day 7

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Dyspnea Visual Analog Scale

Scale range: -100 , +100

-100=worse, +100=better

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

units on a scale

Change from Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Global Visual Analog Scale

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".

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

units on a scale

Change from Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Dyspnea Visual Analog Scale

Scale range: -100 , +100

-100=worse, +100=better

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

units on a scale

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Global Visual Analog Scale

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".

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

units on a scale

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Furosemide-Equivalent Dose

Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Sodium Level

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mEq/L

Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Potassium Level

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mEq/L

Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Urea Nitrogen/Urea

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mg/dL

Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Bicarbonate Level

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mEq/L

Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Hemoglobin Level

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

g/dL

Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Sodium Level

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mEq/L

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Potassium Level

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mEq/L

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Urea Nitrogen/Urea

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mg/dL

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Bicarbonate Level

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mEq/L

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Hemoglobin Level

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

g/dL

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Cystatin C

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mg/L

Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Uric Acid

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mg/dL

Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood N- Terminal Pro- BNP

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

pg/mL

Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Plasma Renin Activity

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

ng/mL/hr

Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood High Sensitivity Troponin I

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

pg/mL

Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Aldosterone

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

pg/mL

Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Procollagen III N-terminal Propepide

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

ug/L

Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Endothelin-1

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

pg/mL

Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood High Sensitivity C-Reactive Protein

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mg/L

Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Carboxy-terminal Telopeptide of Collagen Type I

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

ug/L

Baseline to Day 4

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Cystatin C

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mg/L

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Uric Acid

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mg/dL

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood N Terminal Pro-Natriuretic Peptide

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

pg/mL

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Plasma Renin Activity

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

ng/mL/hr

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood High Sensitivity Troponin I

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

pg/mL

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Aldosterone

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

pg/mL

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Procollagen III N-terminal Propepide

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

ug/L

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Endothelin-1

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

pg/mL

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Carboxy-terminal Telopeptide of Collagen Type I

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

ug/L

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood High Sensitivity C-Reactive Protein

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mg/L

Baseline to Day 7/Discharge

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Weight Change

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

lbs

Baseline to Day 30

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Furosemide-Equivalent Dose

Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

Baseline to Day 30

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Creatinine Change

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mg/dL

Baseline to Day 30

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Glomerular Filtration Rate Change

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mL/min

Baseline to Day 30

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Weight Change

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

lbs

Baseline to Day 60

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Furosemide-Equivalent Dose

Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

Baseline to Day 60

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Best Available Serum Creatinine Change

Core laboratory when available. If not available, local laboratory results were used.

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mg/dL

Baseline to Day 60

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Best Available Glomerular Filtration Rate Change

Core laboratory when available. If not available, local laboratory results were used.

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mL/min

Baseline to Day 60

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Uric Acid

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mg/dL

Baseline to Day 60

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Cystatin C

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mg/L

Baseline to Day 60

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood N Terminal Pro - B Natriuretic Peptides

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

pg/mL

Baseline to Day 60

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Plasma Renin Activity

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

ng/mL/hr

Baseline to Day 60

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood High Sensitivity Troponin I

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

pg/mL

Baseline to Day 60

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Aldosterone

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

pg/mL

Baseline to Day 60

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Procollagen III N-terminal Propepide

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

ug/L

Baseline to Day 60

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Endothelin-1

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

pg/mL

Baseline to Day 60

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood High Sensitivity C-Reactive Protein

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

mg/L

Baseline to Day 60

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Secondary

Change in Blood Carboxy-terminal Telopeptide of Collagen Type I

Participants analyzed consisted of those participants who had the endpoint data available to be derived.

Posted

Mean

Standard Deviation

ug/L

Baseline to Day 60

ID	Title	Description
OG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
OG001	Ultrafiltration	Participants will receive ultrafiltration

Units	Counts
Participants	OG000

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG0005 affected94 at risk EG0016 affected94 at risk
Heparin-Induced Thrombocytopenia	Blood and lymphatic system disorders	EG0000 affected94 at risk EG0011 affected94 at risk
Thrombocytopenia	Blood and lymphatic system disorders	EG0000 affected94 at risk EG0011 affected94 at risk
Acute Coronary Syndrome	Cardiac disorders	EG0000 affected94 at risk EG0011 affected94 at risk
Acute Myocardial Infarction	Cardiac disorders	EG0000 affected94 at risk EG0011 affected94 at risk
Angina Pectoris	Cardiac disorders	EG0001 affected94 at risk EG0011 affected94 at risk
Atrial Fibrillation	Cardiac disorders	EG0001 affected94 at risk EG0012 affected94 at risk
Cardiac Failure	Cardiac disorders	EG00017 affected94 at risk EG00116 affected94 at risk
Cardiac Failure Acute	Cardiac disorders	EG00012 affected94 at risk EG00115 affected94 at risk
Cardiac Failure Chronic	Cardiac disorders	EG0000 affected94 at risk EG0012 affected94 at risk
Pulseless Electrical Activity	Cardiac disorders	EG0001 affected94 at risk EG0010 affected94 at risk
Sinus Tachycardia	Cardiac disorders	EG0000 affected94 at risk EG0011 affected94 at risk
Ventricular Fibrillation	Cardiac disorders	EG0001 affected94 at risk EG0010 affected94 at risk
Ventricular Tachycardia	Cardiac disorders	EG0001 affected94 at risk EG0010 affected94 at risk
Haematuria	Renal and urinary disorders	EG0001 affected94 at risk EG0012 affected94 at risk
Renal Failure	Renal and urinary disorders	EG00011 affected94 at risk EG00110 affected94 at risk
Renal Failure Acute	Renal and urinary disorders	EG0003 affected94 at risk EG0016 affected94 at risk
Renal Failure Chronic	Renal and urinary disorders	EG0002 affected94 at risk EG0010 affected94 at risk
Renal Impairment	Renal and urinary disorders	EG0000 affected94 at risk EG0011 affected94 at risk
Renal Tubular Necrosis	Renal and urinary disorders	EG0000 affected94 at risk EG0011 affected94 at risk
Urinary Tract Obstruction	Renal and urinary disorders	EG0000 affected94 at risk EG0011 affected94 at risk

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

ID	Term
D005112	Extracorporeal Circulation
D013514	Surgical Procedures, Operative
D005374	Filtration
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques
D055585	Physical Phenomena
D055598	Chemical Phenomena

ID	Title	Description
BG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care
BG001	Ultrafiltration	Participants will receive ultrafiltration
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Stepped Pharmacologic Care	Participants will receive stepped pharmacologic care			54	94	0	94
EG001	Ultrafiltration	Participants will receive ultrafiltration			68	94	0	94