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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-12-31

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).

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Detailed Description

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Conditions

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Acute Decompensated Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ultrafiltration group

Group Type ACTIVE_COMPARATOR

ultrafiltration

Intervention Type PROCEDURE

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.

diuretics group

Group Type ACTIVE_COMPARATOR

diuretics

Intervention Type DRUG

Bumetanide continuous infusion to reach a prescribed negative fluid balance: dose adjustment according to the diuretic response.

Interventions

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ultrafiltration

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.

Intervention Type PROCEDURE

diuretics

Bumetanide continuous infusion to reach a prescribed negative fluid balance: dose adjustment according to the diuretic response.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No