CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 188 enrolled
Drug / intervention
Stepped pharmacologic care +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00608491
NCT00608491Phase 3Completed

CARdiorenal REScue Study in Acute Decompensated Heart Failure: CARRESS

Duke University·interventional·Posted Feb 6, 2008·Updated Jun 24, 2013

In Brief

A Phase 3 clinical trial evaluating Stepped pharmacologic care and Ultrafiltration for Heart Failure. Completed, enrolled 188 participants across 9 sites in 2 countries.

Detailed Summary

Heart failure is a serious condition in which the heart's ability to pump blood through the body is impaired, often making a person feel weak or fatigued. When a person's condition worsens to the point of hospitalization, that person is said to have acute decompensated heart failure (ADHF). Abnormal kidney function in association with cardiac distress, known as cardiorenal syndrome, is a common complication of heart failure and causes further medical problems and need for hospitalization. While there are various effective treatments for heart failure, more research is needed to determine the best treatment for targeting both ADHF and cardiorenal syndrome. This study will compare the safety and effectiveness of ultrafiltration versus standard medical drug therapy in improving renal function and relieving fluid buildup in people hospitalized with ADHF and cardiorenal syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesCanada, United States

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2008
Enrollment StartMar 1, 2008
Primary CompletionMar 1, 2012
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 18.4 years ago

Interventions

Stepped pharmacologic caredrug

Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes.

Ultrafiltrationdevice

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.