- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00676234
Recombinant Human Erythropoietin Use in Intensive Care Unit (ICU) Patients: Does it Prevent Acute Renal Failure
Recombinant Human Erythropoietin Use in ICU Patients: Does it Prevent Acute Renal Failure?
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Geneva, Switzerland, 1211
- Nephrology Unit, Geneva University Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1
|
|
Experimental: 2
Administration of intravenous rhu Epo on Day 0
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection
Time Frame: 4 days
|
4 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mean change (%) from baseline in serum Cystatin C concentration at 96 hr after rhu EPO injection
Time Frame: 4 days
|
4 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrick Saudan, Dr, Nephrology Unit Geneva University Hospitals
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-11021991
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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