Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00608491 | Effectiveness of Ultrafiltration in Treating People With Acute Decompensated Heart Failure and Cardiorenal Syndrome (The CARRESS Study) | PHASE3 | COMPLETED | 188 | — | — | Mar 1, 2008 | Jun 1, 2012 | Jun 24, 2013 | 9 | United States, Canada |
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| Ultrafiltration | DEVICE | 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. |
Inclusion criteria: * age 18 or older * admitted to the hospital with a primary diagnosis of decompensated heart failure * onset of cardiorenal syndrome after hospitalization or pre-hospitalization * after hospitalization - onset of cardiorenal syndrome after hospitalization must occur within 10 da...