Forced Diuresis Versus Observation in Resolving Renal Failure After Haemofiltration in Critically Ill Patients
Information source: Medical Centre Leeuwarden
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Failure; Critically Ill
Intervention: Furosemide (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Medical Centre Leeuwarden Official(s) and/or principal investigator(s): Peter van der Voort, MD, PhD, MSc, Principal Investigator, Affiliation: Dept of intensive care, Medical Centre Leeuwarden, PO Box 888,8901BR Leeuwarden, The Netherlands
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.
Clinical Details
Official title: Forced Diuresis Vs Observation in Resolving Renal Failure After Haemofiltration in Critically Ill Patients (Fodorefh)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Creatinin clearance
Secondary outcome: length of stay in the intensive care and hospitalintensive care and hospital mortality
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:
1. Recovery of renal function (clearance more than 30 ml/min)
2. Stable or declining serum creatinin in case of persistent clearance less than 30 ml/min
3. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- cessation of hemofiltration
- mechanical ventilation
- written informed consent
Exclusion Criteria:
- pre-existent renal failure
- glomerulonephritis
Locations and Contacts
Dept of intensive care, Medical Centre Leeuwarden, Leeuwarden, Fr 8901 BR, Netherlands
Additional Information
Starting date: December 2005
Last updated: April 18, 2007
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