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

Study Overview
=================
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).

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

Conditions
-----------------
Acute Renal Failure

Intervention / Treatment
-----------------
* Drug: epoetinum


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br> | |
| Experimental: 2<br>Administration of intravenous rhu Epo on Day 0 | Drug: epoetinum<br>* 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<br>* Other names: Eprex;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection |  | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean change (%) from baseline in serum Cystatin C concentration at 96 hr after rhu EPO injection |  | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
erythropoietin