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

Sponsor

University Hospital, Ghent (Other)

Overall Status

Completed

CT.gov ID

NCT01138683

Collaborator

(none)

Enrollment

Location

Arms

21.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Decompensated Heart Failure	Procedure: ultrafiltration Drug: diuretics	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ultrafiltration group	Procedure: 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.
Active Comparator: diuretics group	Drug: diuretics Bumetanide continuous infusion to reach a prescribed negative fluid balance: dose adjustment according to the diuretic response.

Arm

Intervention/Treatment

Active Comparator: ultrafiltration group

Procedure: 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.

Active Comparator: diuretics group

Drug: diuretics

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator: Sofie Gevaert, MD, University Hospital Ghent, Belgium

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

website of University Hospital Ghent

Publications

None provided.

Responsible Party:

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT01138683

Other Study ID Numbers:

2009/539
2009-017589-22

First Posted:

Jun 7, 2010

Last Update Posted:

Jan 10, 2012

Last Verified:

Jan 1, 2012

Keywords provided by University Hospital, Ghent

Acute decompensated heart failure

ultrafiltration

diuretics

AKI

Additional relevant MeSH terms:

Heart Failure

Diuretics

Study Results

No Results Posted as of Jan 10, 2012