Cardiorenal Interactions During Treatment of Acute Decompensated Heart Failure: Diuretics Versus Ultrafiltration

Study Overview
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Brief Summary
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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).

Official Title
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Cardiorenal Interactions During Treatment of Acute Decompensated Heart Failure: Diuretics Versus Ultrafiltration

Conditions
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Acute Decompensated Heart Failure

Intervention / Treatment
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* Procedure: ultrafiltration
* Drug: diuretics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ultrafiltration group<br> | Procedure: ultrafiltration<br>* 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.<br>|
| Active Comparator: diuretics group<br> | Drug: diuretics<br>* Bumetanide continuous infusion to reach a prescribed negative fluid balance: dose adjustment according to the diuretic response.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute decompensated heart failure, ultrafiltration, diuretics, AKI