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

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

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.

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).

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

Inclusion Criteria: Patients at risks for acute tubular necrosis (patients with mechanical ventilation, patients with sepsis, in the post-operative state, with hemodynamic impairment or with previous chronic renal failure. Consent form signed Exclusion Criteria: Patients with malignant hypertension Patients with systolic BP > 150 mmHg at enrollment Patients with Hb level > 120g/L Patients with acute coronaropathy Pregnancy Patients with urine output < 600 ml/12 h

de Seigneux S, Ponte B, Weiss L, Pugin J, Romand JA, Martin PY, Saudan P. Epoetin administrated after cardiac surgery: effects on renal function and inflammation in a randomized controlled study. BMC Nephrol. 2012 Oct 3;13:132. doi: 10.1186/1471-2369-13-132.