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

University Hospitals (UH)

Status and phase

Completed

Phase 2

Conditions

Acute Renal Failure

Treatments

Drug: epoetinum

Study type

Interventional

Funder types

Other

Identifiers

NCT00676234

2008-11021991

Details and patient eligibility

About

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.

Full 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).

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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