Effectiveness of Ultrafiltration in Treating People With Acute Decompensated Heart Failure and Cardiorenal Syndrome (The CARRESS Study)

PHASE3CompletedINTERVENTIONAL
Enrollment

188

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

March 31, 2012

Study Completion Date

June 30, 2012

Conditions
Heart Failure
Interventions
DRUG

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.

DEVICE

Ultrafiltration

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.

Trial Locations (9)

27705

Duke University Medical Center, Durham

30310

Morehouse School of Medicine, Atlanta

55415

Minnesota Heart Failure Network, Minneapolis

55905

Mayo Clinic, Rochester

77030

Baylor College of Medicine, Houston

84107

University of Utah Health Sciences Center, Murray

85054

Mayo Clinic Arizona, Phoenix

05401

University of Vermont - Fletcher Allen Health Care, Burlington

H1T - 1C8

Montreal Heart Institute, Montreal

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Nuwellis, Inc.

INDUSTRY

lead

Duke University

OTHER

NCT00608491 - Effectiveness of Ultrafiltration in Treating People With Acute Decompensated Heart Failure and Cardiorenal Syndrome (The CARRESS Study) | Biotech Hunter | Biotech Hunter