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

University Hospital, Geneva80 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Renal Failure

Interventions

epoetinumDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Nephrology Unit, Geneva University Hospitals

Geneva, Canton of Geneva, Switzerland

Outcomes

Primary Outcomes

mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection

Time frame: 4 days

Secondary Outcomes

mean change (%) from baseline in serum Cystatin C concentration at 96 hr after rhu EPO injection

Time frame: 4 days

Data from ClinicalTrials.gov

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