Clinical trial NCT00676234: Recombinant Human Erythropoietin Use in Intensive Care Unit (ICU) Patients: Does it Prevent Acute Renal Failure
Official title: Recombinant Human Erythropoietin Use in ICU Patients: Does it Prevent Acute Renal Failure?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Renal Failure
Keywords: erythropoietin
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2008-05-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection
timeFrame: 4 days
Secondary outcomes:
measure: mean change (%) from baseline in serum Cystatin C concentration at 96 hr after rhu EPO injection
timeFrame: 4 days
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Nephrology Unit, Geneva University Hospitals
Study officials:
affiliation: Nephrology Unit Geneva University Hospitals
name: Patrick Saudan, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.