Recombinant Human Erythropoietin Use in Intensive Care Unit (ICU) Patients: Does it Prevent Acute Renal Failure
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 7, 2008
CompletedFirst Posted
Study publicly available on registry
May 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJune 30, 2009
June 1, 2009
1.1 years
May 7, 2008
June 26, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection
4 days
Secondary Outcomes (1)
mean change (%) from baseline in serum Cystatin C concentration at 96 hr after rhu EPO injection
4 days
Study Arms (2)
1
NO INTERVENTION2
EXPERIMENTALAdministration of intravenous rhu Epo on Day 0
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nephrology Unit, Geneva University Hospitals
Geneva, Canton of Geneva, 1211, Switzerland
Related Publications (2)
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.
PMID: 39301879DERIVEDde 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.
PMID: 23033926DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Saudan, Dr
Nephrology Unit Geneva University Hospitals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 7, 2008
First Posted
May 12, 2008
Study Start
May 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
June 30, 2009
Record last verified: 2009-06