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

Information source: University Hospital, Geneva
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Renal Failure

Intervention: epoetinum (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University Hospital, Geneva

Official(s) and/or principal investigator(s):
Patrick Saudan, Dr, Principal Investigator, Affiliation: Nephrology Unit Geneva University Hospitals

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.

Clinical Details

Official title: Recombinant Human Erythropoietin Use in ICU Patients: Does it Prevent Acute Renal Failure?

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection

Secondary outcome: mean change (%) from baseline in serum Cystatin C concentration at 96 hr after rhu EPO injection

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Nephrology Unit, Geneva University Hospitals, Geneva 1211, Switzerland
Additional Information

Starting date: May 2008
Last updated: June 26, 2009

Page last updated: August 23, 2015

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