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

Phase 2

Completed

• Conditions: Acute Renal Failure
• Interventions: Drug: epoetinum

• Registration Number: NCT00676234
• Lead Sponsor: University Hospital, Geneva

Brief 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).

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-07
• Study First Submitted QC: 2008-05-09
• Study First Posted: 2008-05-12
• Status Verified: 2009-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Last Update Submitted: 2009-06-26
• Last Update Posted: 2009-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	epoetinum	Administration of intravenous rhu Epo on Day 0

Primary Outcome Measures

Name	Time	Method
mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection	4 days

Secondary Outcome Measures

Name	Time	Method
mean change (%) from baseline in serum Cystatin C concentration at 96 hr after rhu EPO injection	4 days

Trial Locations

Locations (1)

Nephrology Unit, Geneva University Hospitals; 🇨🇭 Geneva, Switzerland