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

Acute Decompensated Heart Failure Clinical Trial

— CRUF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138683
• Other study ID #: 2009/539
• Secondary ID: 2009-017589-22
• Status: Completed
• Phase: Phase 3
• First received: June 4, 2010
• Last updated: January 9, 2012
• Start date: February 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

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.

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

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of AKI and determining factors in patients with acute decompensated heart failure with treated with ultrafiltration versus diuretics		at 6 months	No
Secondary	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	No
Secondary	Combined endpoint of mortality/rehospitalisation-urgent outpatient visit due to heart failure		at 6 months	No
Secondary	Kidney function measured by creatinine		after 28 days and 6 months	No

External Links

•   website of University Hospital Ghent