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OpenTrials
Completed

NCT Number: NCT01138683

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

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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Key information

Conditions

Acute Decompensated Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Ghent

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Diuretics

Drug

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

Primary outcomes

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

    Time frame: at 6 months

Secondary outcomes

  1. 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

  2. Combined endpoint of mortality/rehospitalisation-urgent outpatient visit due to heart failure

    Time frame: at 6 months

  3. Kidney function measured by creatinine

    Time frame: after 28 days and 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: CRUF

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 7, 2010
Registry last updated
Jan 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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