Recombinant Human Erythropoietin Use in Intensive Care Unit (ICU) Patients: Does it Prevent Acute Renal Failure
NCT ID: NCT00676234
Last Updated: 2009-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2008-05-31
2009-06-30
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
No interventions assigned to this group
2
Administration of intravenous rhu Epo on Day 0
epoetinum
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
Interventions
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epoetinum
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Consent form signed
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Geneva
OTHER
Responsible Party
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Nephrology Unit
Principal Investigators
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Patrick Saudan, Dr
Role: PRINCIPAL_INVESTIGATOR
Nephrology Unit Geneva University Hospitals
Locations
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Nephrology Unit, Geneva University Hospitals
Geneva, Canton of Geneva, Switzerland
Countries
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References
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Nishiwaki H, Abe Y, Suzuki T, Hasegawa T, Levack WM, Noma H, Ota E. Erythropoiesis-stimulating agents for preventing acute kidney injury. Cochrane Database Syst Rev. 2024 Sep 20;9(9):CD014820. doi: 10.1002/14651858.CD014820.pub2.
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.
Other Identifiers
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2008-11021991
Identifier Type: -
Identifier Source: org_study_id