Acute Decompensated Heart Failure
Conditions
Keywords
Acute decompensated heart failure, ultrafiltration, diuretics, AKI
Brief summary
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).
Interventions
PROCEDUREultrafiltration
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.
DRUGdiuretics
Bumetanide continuous infusion to reach a prescribed negative fluid balance: dose adjustment according to the diuretic response.
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>18 years old * Severe systolic heart failure with ejection fraction \<40% * And Hospitalisation for decompensated heart failure * And New York Heart Association (NYHA) III or IV * And 1 of the following: * Jugular vein distension\>6cm * Tissue Doppler mitral annulus lateral\>12 or medial\>15 * Chest X-ray: pulmonary edema or pleural effusion
Exclusion criteria
* Need for inotropic or vasopressive agents * Use of intravenous (IV) contrast media * Acute coronary syndrome * Need of dialysis * Severe co-morbidity * Contra-indications for anticoagulation * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of AKI and determining factors in patients with acute decompensated heart failure with treated with ultrafiltration versus diuretics | at 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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. | at 48h after treatment start |
| Combined endpoint of mortality/rehospitalisation-urgent outpatient visit due to heart failure | at 6 months |
| Kidney function measured by creatinine | after 28 days and 6 months |
Countries
Belgium
Outcome results
None listed