Cardiorenal Interactions During Treatment of Acute Decompensated Heart Failure: Diuretics Versus Ultrafiltration (CRUF)
The CRUF trial is a prospective randomized monocentric trial comparing different impact of diuretics versus ultrafiltration on renal congestion, plasma refill rate, echocardiographic filling pressures, neurohormonal activation and biomarkers of Acute Kidney Injury (AKI).
Acute Decompensated Heart Failure
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cardiorenal Interactions During Treatment of Acute Decompensated Heart Failure: Diuretics Versus Ultrafiltration|
- Incidence of AKI and determining factors in patients with acute decompensated heart failure with treated with ultrafiltration versus diuretics [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
- determination of the value of Neutrophil gelatinase-associated lipocalin (NGAL) to predict AKI in acute decompensated heart failure (vs creatinine, Cystatin C,measured urinary creatinine clearance) in patients treated with diuretics vs ultrafiltration. [ Time Frame: at 48h after treatment start ] [ Designated as safety issue: No ]
- Combined endpoint of mortality/rehospitalisation-urgent outpatient visit due to heart failure [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
- Kidney function measured by creatinine [ Time Frame: after 28 days and 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: ultrafiltration group||
Ultrafiltration through double lumen catheter, via central vein (Vena jugularis interna or Vena femoralis, 11 French, 15 cm for right jugular or 20 cm for femoralis and jugularis left-position). Based on severity of fluid overload the cardiologist determines the ultrafiltration rate. 'Multifiltrate Fresenius' (extracorporeal blood volume 72ml) in SCUF (slow continuous ultrafiltration) modus with pediatric lines (54 ml extracorporeal volume in the AV-set) and a pediatric filter (Ultraflux® AV paed, blood volume 18ml). Heparin to maintain an APTT between 65 en 85 seconds during ultrafiltration.
|Active Comparator: diuretics group||
Bumetanide continuous infusion to reach a prescribed negative fluid balance: dose adjustment according to the diuretic response.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138683
|University Hospital Ghent|
|Principal Investigator:||Sofie Gevaert, MD||University Hospital Ghent, Belgium|