Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT00676234
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.
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:
NCT00676234
Study Brief:
Protocol Section:
NCT00676234