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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00676234
First received: May 7, 2008
Last updated: June 26, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Renal Failure
 Drug: epoetinum
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Recombinant Human Erythropoietin Use in ICU Patients: Does it Prevent Acute Renal Failure?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean change (%) from baseline in serum Cystatin C concentration at 96 hr after rhu EPO injection [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Experimental: 2
Administration of intravenous rhu Epo on Day 0
 Drug: 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 Name: Eprex

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676234

Locations
Switzerland
Nephrology Unit, Geneva University Hospitals
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Patrick Saudan, Dr Nephrology Unit Geneva University Hospitals
  More Information

No publications provided by University Hospital, Geneva

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr P. Saudan, Nephrology Unit
ClinicalTrials.gov Identifier: NCT00676234     History of Changes
Other Study ID Numbers: 2008-11021991
Study First Received: May 7, 2008
Last Updated: June 26, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
erythropoietin

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Epoetin Alfa
 Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013