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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01138683
First received: June 4, 2010
Last updated: January 9, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Acute Decompensated Heart Failure
 Procedure: ultrafiltration
Drug: diuretics
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardiorenal Interactions During Treatment of Acute Decompensated Heart Failure: Diuretics Versus Ultrafiltration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Incidence of AKI and determining factors in patients with acute decompensated heart failure with treated with ultrafiltration versus diuretics [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

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. [ Time Frame: at 48h after treatment start ] [ Designated as safety issue: No ]
  • Combined endpoint of mortality/rehospitalisation-urgent outpatient visit due to heart failure [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Kidney function measured by creatinine [ Time Frame: after 28 days and 6 months ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: February 2010
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138683

Locations
Belgium
University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Sofie Gevaert, MD University Hospital Ghent, Belgium
  More Information

Additional Information:
website of University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01138683     History of Changes
Other Study ID Numbers: 2009/539, 2009-017589-22
Study First Received: June 4, 2010
Last Updated: January 9, 2012
Health Authority: Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Ghent:
Acute decompensated heart failure
ultrafiltration
diuretics
AKI

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Diuretics
 Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013