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

NCT01138683 | Completed Phase 3

• 2 other identifiers: 2009/5392009-017589-22
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Decompensated Heart Failure

Keywords

Acute decompensated heart failure; ultrafiltration; diuretics; AKI

Outcome Measures

Primary Outcomes (1)

• Incidence of AKI and determining factors in patients with acute decompensated heart failure with treated with ultrafiltration versus diuretics

  at 6 months

Secondary Outcomes (3)

• 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

Study Arms (2)

ultrafiltration group

ACTIVE COMPARATOR

Procedure: ultrafiltration

diuretics group

ACTIVE COMPARATOR

Drug: diuretics

Interventions

ultrafiltration 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.

ultrafiltration group

diuretics DRUG

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

diuretics group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

Location

Related Links

• website of University Hospital Ghent

MeSH Terms

Interventions

Ultrafiltration; Diuretics

Intervention Hierarchy (Ancestors)

Extracorporeal Circulation; Surgical Procedures, Operative; Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Physical Phenomena; Chemical Phenomena; Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Sofie Gevaert, MD

  University Hospital Ghent, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 7, 2010
• Study Start: February 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 10, 2012

Record last verified: 2012-01

Locations

BE (1)