search
Back to results

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

Primary Purpose

Acute Decompensated Heart Failure

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
ultrafiltration
diuretics
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Decompensated Heart Failure focused on measuring Acute decompensated heart failure, ultrafiltration, diuretics, AKI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ultrafiltration group

diuretics group

Arm Description

Outcomes

Primary Outcome Measures

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

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.
Combined endpoint of mortality/rehospitalisation-urgent outpatient visit due to heart failure
Kidney function measured by creatinine

Full Information

First Posted
June 4, 2010
Last Updated
January 9, 2012
Sponsor
University Hospital, Ghent
search

1. Study Identification

Unique Protocol Identification Number
NCT01138683
Brief Title
Cardiorenal Interactions During Treatment of Acute Decompensated Heart Failure: Diuretics Versus Ultrafiltration
Acronym
CRUF
Official Title
Cardiorenal Interactions During Treatment of Acute Decompensated Heart Failure: Diuretics Versus Ultrafiltration
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure
Keywords
Acute decompensated heart failure, ultrafiltration, diuretics, AKI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ultrafiltration group
Arm Type
Active Comparator
Arm Title
diuretics group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
ultrafiltration
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
diuretics
Intervention Description
Bumetanide continuous infusion to reach a prescribed negative fluid balance: dose adjustment according to the diuretic response.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Combined endpoint of mortality/rehospitalisation-urgent outpatient visit due to heart failure
Time Frame
at 6 months
Title
Kidney function measured by creatinine
Time Frame
after 28 days and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofie Gevaert, MD
Organizational Affiliation
University Hospital Ghent, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
website of University Hospital Ghent

Learn more about this trial

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

We'll reach out to this number within 24 hrs