Forced Diuresis Versus Observation in Resolving Renal Failure After Haemofiltration in Critically Ill Patients

This study has been terminated.
(Number included has been reached)
Sponsor:
Information provided by:
Medical Centre Leeuwarden
ClinicalTrials.gov Identifier:
NCT00298454
First received: March 1, 2006
Last updated: April 18, 2007
Last verified: April 2007

March 1, 2006
April 18, 2007
December 2005
Not Provided
Creatinin clearance
Same as current
Complete list of historical versions of study NCT00298454 on ClinicalTrials.gov Archive Site
  • length of stay in the intensive care and hospital
  • intensive care and hospital mortality
Same as current
Not Provided
Not Provided
 
Forced Diuresis Versus Observation in Resolving Renal Failure After Haemofiltration in Critically Ill Patients
Forced Diuresis Vs Observation in Resolving Renal Failure After Haemofiltration in Critically Ill Patients (Fodorefh)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Renal Failure
  • Critically Ill
Drug: Furosemide
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
72
April 2007
Not Provided

Inclusion Criteria:

  • cessation of hemofiltration
  • mechanical ventilation
  • written informed consent

Exclusion Criteria:

  • pre-existent renal failure
  • glomerulonephritis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00298454
200601
Not Provided
Not Provided
Medical Centre Leeuwarden
Not Provided
Principal Investigator: Peter van der Voort, MD, PhD, MSc Dept of intensive care, Medical Centre Leeuwarden, PO Box 888,8901BR Leeuwarden, The Netherlands
Medical Centre Leeuwarden
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP