Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Thammasat University
ClinicalTrials.gov Identifier:
NCT01066351
First received: February 9, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

The purpose of this study is to demonstrate the efficacy of erythropoietin for prevention acute kidney injury in CKD patients undergoing cardiac surgery.


Condition Intervention Phase
Acute Renal Failure
Drug: beta erythropoietin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Thammasat University:

Primary Outcome Measures:
  • The primary end-point of this study is the development of AKI in placebo group compared with EPO group. [ Time Frame: 1.5 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary end-point of this study is compare urine NGAL level in AKI patients between both groups [ Time Frame: 1.5 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erythropoietin
The patients were assigned to receive beta erythropoietin (Recormon) dose 200 unit/kg at 3 day before cardiac surgery and 100 unit/kg in the morning before cardiac surgery.
Drug: beta erythropoietin
The patients were assigned to receive beta erythropoietin (Recormon) dose 200 unit/kg at 3 day before cardiac surgery and 100 unit/kg in the morning before cardiac surgery.
Other Name: Recormon
Placebo Comparator: placebo
The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery.
Drug: placebo
The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery.
Other Name: normal saline

Detailed Description:

Acute kidney injury (AKI)occur 7.7-42% after cardiac surgery. The incidence of AKI requiring renal replacement therapy following coronary artery bypass grafting (CABG) surgery was 0.7-3.5% and increase mortality rate. Erythropoietin (EPO) is now considered a novel anti-apoptotic and anti-inflammatory action. The present study was designed to evaluate the administration of EPO as a means of preventing AKI in these patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18 years.
  • serum creatinine levels > 1.2 mg/dL and baseline creatinine clearance levels < 60 mL/min (as measured in their most recent sample,drawn within 2 months prior to the beginning of the study)
  • patients who need cardiac surgery

Exclusion Criteria:

  • patients with acute kidney injury
  • end stage renal disease (requiring dialysis)
  • unstable renal function (as evidenced by a change in serum creatinine of > 0.5 mg/dL, or > 25%, within 14 days prior to the study)
  • allergy to any of erythropoietin
  • suffered from congestive heart failure, cardiogenic shock or emergent cardiac surgery.
  • receiving erythropoietin within 14 days before the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066351

Locations
Thailand
Adis Tasanarong
Khlong Luang, Pathumtani, Thailand, 12121
Sponsors and Collaborators
Thammasat University
Investigators
Principal Investigator: Adis Tasanarong, MD Thammasat Universuty
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Adis Tasanarong, Faculty of Medicine, Thammasat University (Rangsit Campus)
ClinicalTrials.gov Identifier: NCT01066351     History of Changes
Other Study ID Numbers: MTU-E-1-57/52
Study First Received: February 9, 2010
Last Updated: February 9, 2010
Health Authority: Thailand: Ethical Committee

Keywords provided by Thammasat University:
acute kidney injury
erythropoietin
cardiac surgery

Additional relevant MeSH terms:
Kidney Diseases
Acute Kidney Injury
Renal Insufficiency
Renal Insufficiency, Chronic
Wounds and Injuries
Urologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014