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| Sponsor: | Medical Centre Leeuwarden |
|---|---|
| Information provided by: | Medical Centre Leeuwarden |
| ClinicalTrials.gov Identifier: | NCT00298454 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Failure Critically Ill |
Drug: Furosemide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Forced Diuresis Vs Observation in Resolving Renal Failure After Haemofiltration in Critically Ill Patients (Fodorefh) |
| Estimated Enrollment: | 72 |
| Study Start Date: | December 2005 |
| Study Completion Date: | April 2007 |
Hide Detailed DescriptionIntroduction:
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:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Netherlands, Fr | |
| Dept of intensive care, Medical Centre Leeuwarden | |
| Leeuwarden, Fr, Netherlands, 8901 BR | |
| Principal Investigator: | Peter van der Voort, MD, PhD, MSc | Dept of intensive care, Medical Centre Leeuwarden, PO Box 888,8901BR Leeuwarden, The Netherlands |
More Information
| Study ID Numbers: | 200601 |
| Study First Received: | March 1, 2006 |
| Last Updated: | April 18, 2007 |
| ClinicalTrials.gov Identifier: | NCT00298454 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
renal failure oliguric critically ill furosemide |
|
Disease Attributes Renal Insufficiency Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Diuretics Cardiovascular Agents Furosemide Pharmacologic Actions Membrane Transport Modulators |
Pathologic Processes Urologic Diseases Natriuretic Agents Critical Illness Therapeutic Uses Kidney Diseases Sodium Potassium Chloride Symporter Inhibitors Kidney Failure |
