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Prevention of Acute Kidney Injury by Erythropoietin in Thoracic Aorta Surgery With Hypothermic Cardiac Arrest

This study is not yet open for participant recruitment.
Verified January 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yon Hee Shim, Yonsei University
ClinicalTrials.gov Identifier:
NCT01369732
First received: June 3, 2011
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

During thoracic aortic surgery, hypothermic cardiac arrest causes aortic ischemia and reperfusion (IR) periods, respectively. Aortic ischemia results in an ischemic insult to the lower extremities and successive reperfusion results in injury to remote organs, including kidneys. So, there has been considerable interest in the development of therapeutic strategies aimed at attenuating IR injury. One such group of agents that are attracting interest due to their potential protective effects on vascular endothelium is the erythropoietin.

However, the effect of erythropoietin on renal injury induced by aortic IR in humane has not been fully clarified. Therefore, the purpose of this study is to determine whether the prophylactic administration of erythropoietin reduce the incidence of acute kidney injury (AKI) in patients undergoing thoracic aorta surgery with hypothermic cardiac arrest. The investigators administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. The differences between the control and study groups are observed by clinical indicators such as serum creatinine, TNF-α, NGAL.


Condition Intervention Phase
Dissection of Thoracic Aorta
 Drug: recombinant human erythropoietin
Drug: saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Acute Kidney Injury by Erythropoietin in Patients Undergoing Thoracic Aorta Surgery With Hypothermic Cardiac Arrest

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • incidence of acute kidney injury based on RIFLE criteria [ Time Frame: upto 7 days after surgery ] [ Designated as safety issue: No ]
    Serum creatinine, GFR, urine output will be measured at 6:00 AM everyday up to 7 days after surgery.


Secondary Outcome Measures:
  • mortality [ Time Frame: upto 1 month after surgery ] [ Designated as safety issue: No ]
    Participants will be followed for the mortality, an expected average of 1 month after surgery.

  • the duration of mechanical ventilation [ Time Frame: upto 2 weeks after surgery ] [ Designated as safety issue: No ]
    Participants will be followed for the duration of mechanical ventilation, an expected average of 2 weeks after surgery.

  • the duration of ICU stay [ Time Frame: upto 2 weeks after surgery ] [ Designated as safety issue: No ]
    Participants will be followed for the duration of ICU stay, an expected average of 2 weeks after surgery.

  • the duration of hospital stay [ Time Frame: upto 1 month after surgery ] [ Designated as safety issue: No ]
    Participants will be followed for the duration of hospital stay, an expected average of 1 month after surgery.


Estimated Enrollment: 90
Study Start Date: July 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline group
We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
 Drug: saline
We administrate the saline single bolus (5ml intravenously) 30 min before the commencement of ischemia.
Other Name: normal saline
Experimental: erythropoietin group
We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
 Drug: recombinant human erythropoietin
We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
Other Name: epocaine

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults above age of 20
  2. Undergoing Thoracic Aorta Surgery with Hypothermic Cardiac Arrest

Exclusion Criteria:

  1. pregnancy or lactation
  2. cerebrovascular thrombosis 3. past history of pulmonary embolism or thrombosis
  3. past history of thoracic aortic surgery
  4. malignancy 5. preoperative acute kidney injury
  5. chronic renal replacement therapy
  6. allergy or hypersensitivity to erythropoetin
  7. history of erythropoetin treatment
  8. death during or one day after surgery
  9. no consent
  10. reoperation within seven days of the first surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369732

Contacts
Contact: Yon Hee Shim 82-2-2019-6808 tren125@yuhs.ac
Contact: Ji Eun Kim 82-2-2019-6080 beye98@yuhs.ac

Locations
Korea, Republic of
Gangnam severance hospital Not yet recruiting
Seoul, Korea, Republic of, 135-720
Sponsors and Collaborators
Yonsei University
Investigators
Study Director: Yon Hee Shim Yonsei University
  More Information

No publications provided

Responsible Party: Yon Hee Shim, Yonsei University College of Medicine, Yonsei University
ClinicalTrials.gov Identifier: NCT01369732     History of Changes
Other Study ID Numbers: 3-2011-0086
Study First Received: June 3, 2011
Last Updated: January 27, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Acute Kidney Injury
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms
Renal Insufficiency
 Kidney Diseases
Urologic Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013