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NCT Number: NCT00676234

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

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.

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Key information

Conditions

Acute Renal Failure Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nephrology Unit, Geneva University Hospitals

Geneva, Canton of Geneva, 1211, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epoetinum

Drug

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: Eprex

Primary outcomes

  1. mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection

    Time frame: 4 days

Secondary outcomes

  1. mean change (%) from baseline in serum Cystatin C concentration at 96 hr after rhu EPO injection

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 12, 2008
Registry last updated
Jun 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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