NCT00676234

Recombinant Human Erythropoietin Use in Intensive Care Unit (ICU) Patients: Does it Prevent Acute Renal Failure

Recombinant Human Erythropoietin Use in ICU Patients: Does it Prevent Acute Renal Failure?

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pilot study aiming to assess the effect of two doses of rhu EPO on urine NGAL concentration and on serum cystatin C and creatinine levels in critically ill patients at risk of ARF.

Detailed description

Research plan Open-label randomized trial Twelve months duration trial Setting: Medical and Surgical Intensive Care Unit of the University Hospitals of Geneva Start of trial: Mid-May 2008 Patients randomly allocated to 2 treatment groups (20 patients per group), or a control group (40 patients): * Group 1: control group (40 patients) * Group 2 : 20000 IU rhu Epo (20 patients) administered by the i.v. route * Group 3 : 40000 IU rhu Epo (20 patients) administered by the i.v. route 3.2. Trial design Day 0 Consent form signed Patients randomly allocated to control or treatment groups (20000 and 40000 IU) Serum Cystatin C determination Serum Creatinine determination Urinary NGAL determination Administration of intravenous rhu Epo on Day 0 or no Epo (control group) Day 2 At 48 hr after rhu EPO injection, samples will be taken for * Serum Cystatin C determination * Serum Creatinine determination * Urinary NGAL determination Day 4 At 96 hr after rhu EPO injection, samples will be taken for * Serum Cystatin C determination * Serum Creatinine determination * Urinary NGAL determination Stopping rules The trial for an individual subject, parts of the trial or the entire trial will be stopped when: * at Day 4 for an individual subject * after enrollment of 80 patients Treatment The treatment will consist of intravenous (i.v.) injections of recombinant human erythropoietin (r-hu-EPO). The trial medication will be provided by JANSSEN-CILAG AG. The brand name is EPREX® which is epoietinum-alpha in sterile buffered solution for i.v. or s.c. injection. Patient group 1 will not receive EPO treatment. Patient group 2 will receive 20'000 U of rhu EPO and patient group 3 will receive 40'000 U of rhu EPO (i.v. route).

Conditions

• Acute Renal Failure

Interventions

Type	Name	Description
DRUG	epoetinum	Administration of intravenous rhu Epo on Day 0 20000 IU rhu Epo (20 patients) administered by the i.v. route 40000 IU rhu Epo (20 patients) administered by the i.v. route

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-05-12
• Last updated: 2009-06-30

Locations

1 site across 1 country: Switzerland