Forced Diuresis Versus Observation in Resolving Renal Failure After Haemofiltration in Critically Ill Patients
Primary Purpose
Renal Failure, Critically Ill
Status
Terminated
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Furosemide
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure focused on measuring renal failure, oliguric, critically ill, furosemide
Eligibility Criteria
Inclusion Criteria: cessation of hemofiltration mechanical ventilation written informed consent Exclusion Criteria: pre-existent renal failure glomerulonephritis
Sites / Locations
- Dept of intensive care, Medical Centre Leeuwarden
Outcomes
Primary Outcome Measures
Creatinin clearance
Secondary Outcome Measures
length of stay in the intensive care and hospital
intensive care and hospital mortality
Full Information
NCT ID
NCT00298454
First Posted
March 1, 2006
Last Updated
April 18, 2007
Sponsor
Medical Centre Leeuwarden
1. Study Identification
Unique Protocol Identification Number
NCT00298454
Brief Title
Forced Diuresis Versus Observation in Resolving Renal Failure After Haemofiltration in Critically Ill Patients
Official Title
Forced Diuresis Vs Observation in Resolving Renal Failure After Haemofiltration in Critically Ill Patients (Fodorefh)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Why Stopped
Number included has been reached
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical Centre Leeuwarden
4. Oversight
5. Study Description
Brief Summary
Intensive care patients with multiple organ dysfunction syndrome often show renal failure with the need for hemofiltration. Resolving renal failure after cessation of hemofiltration may or may not be accompanied by oliguria. Whether or not the administration of diuretics at that moment is appropriate is not known. The study randomises between furosemide or placebo when hemofiltration is stopped. Study endpoint is recovery of renal function.
Detailed Description
Introduction:
Virtually all intensive care (IC) patients with prolonged IC stay have multiple organ dysfunction syndrome. Frequently renal failure is present. The resolution of renal failure is often relatively late. After cessation of hemofiltration, oliguria may be present, at least for some time. Increasing diuresis by diuretics will probably increase clearance. As a result, intensive care stay and outcome may improve. However, diuretics might also be harmful as it is when applied in developing renal failure.
Aim of the study:
To study whether the stimulation of diuresis by furosemide when hemofiltration is stopped enhances renal recovery and secondary shortens the length of IC-stay.
Setting:
IC-patients treated at the Medical Centre Leeuwarden with MODS and renal failure are included when hemofiltration is stopped. The ICU is mixed medical and surgical, 16 beds with full time intensivists responsible for hemofiltration.
Study design:
Prospective randomised placebo controlled single centre trial.
Methods:
Inclusion criteria. Patients with mechanical ventilation in whom hemofiltration is stopped. Written informed consent must be obtained.
Excluded are patients with pre-existent serum creatinin of 150 umol/l or clearance less than 30 ml/min. Patients admitted with renal failure as the primary admission diagnosis in case acute renal failure is due to glomerulonephritis.
Creatinin clearance is measured in a 4 hour period directly after cessation of hemofiltration. The patient is then randomised for furosemide or sodium chloride. Furosemide is administered at 0.5 mg/kg/hour. Dehydration is prevented by infusing the patient the volume of their diuresis.
Daily creatinin clearance is calculated.
Primary endpoints:
Recovery of renal function (clearance more than 30 ml/min)
Stable or declining serum creatinin in case of persistent clearance less than 30 ml/min
Need for re-start of renal replacement therapy (metabolic acidosis, hyperkalaemia, fluid overload, uremia or uremic complications)
Secondary endpoints:
Length of stay ICU, mortality.
Poweranalysis:
36 patients per group for alpha 0.05 and beta 0.8 and 30% faster recovery of renal failure for the intervention group.
Statistical analysis:
Student t for normally distributed variables, otherwise non-parametric tests. Kaplan Meier and Cox regression for time to recovery of renal function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, Critically Ill
Keywords
renal failure, oliguric, critically ill, furosemide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
72 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Furosemide
Primary Outcome Measure Information:
Title
Creatinin clearance
Secondary Outcome Measure Information:
Title
length of stay in the intensive care and hospital
Title
intensive care and hospital mortality
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cessation of hemofiltration
mechanical ventilation
written informed consent
Exclusion Criteria:
pre-existent renal failure
glomerulonephritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter van der Voort, MD, PhD, MSc
Organizational Affiliation
Dept of intensive care, Medical Centre Leeuwarden, PO Box 888,8901BR Leeuwarden, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of intensive care, Medical Centre Leeuwarden
City
Leeuwarden
State/Province
Fr
ZIP/Postal Code
8901 BR
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
19114909
Citation
van der Voort PH, Boerma EC, Koopmans M, Zandberg M, de Ruiter J, Gerritsen RT, Egbers PH, Kingma WP, Kuiper MA. Furosemide does not improve renal recovery after hemofiltration for acute renal failure in critically ill patients: a double blind randomized controlled trial. Crit Care Med. 2009 Feb;37(2):533-8. doi: 10.1097/CCM.0b013e318195424d.
Results Reference
derived
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Forced Diuresis Versus Observation in Resolving Renal Failure After Haemofiltration in Critically Ill Patients
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