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Completed

NCT Number: NCT01369732

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gangnam severance hospital

Seoul, 135-720, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults above age of 20
  • Undergoing Thoracic Aorta Surgery with Hypothermic Cardiac Arrest

Exclusion criteria

  • pregnancy or lactation
  • cerebrovascular thrombosis 3. past history of pulmonary embolism or thrombosis
  • past history of thoracic aortic surgery
  • malignancy 5. preoperative acute kidney injury
  • chronic renal replacement therapy
  • allergy or hypersensitivity to erythropoetin
  • history of erythropoetin treatment
  • death during or one day after surgery
  • no consent
  • reoperation within seven days of the first surgery

Treatment and study plan

Recombinant human erythropoietin

Drug

We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.

Other names: epocaine

Saline

Drug

We administrate the saline single bolus (5ml intravenously) 30 min before the commencement of ischemia.

Other names: normal saline

Primary outcomes

  1. Incidence of Acute Kidney Injury Based on RIFLE Criteria

    Time frame: upto 7 days after surgery

    Serum creatinine, GFR, urine output will be measured at 6:00 AM everyday up to 7 days after surgery.

  2. Incidence of Acute Kidney Injury Based on RIFLE Criteria

    Time frame: upto 7 days after surgery

Secondary outcomes

  1. Mortality

    Time frame: upto 1 month after surgery

    Participants will be followed for the mortality, an expected average of 1 month after surgery.

  2. the Duration of Mechanical Ventilation

    Time frame: upto 2 weeks after surgery

    Participants will be followed for the duration of mechanical ventilation, an expected average of 2 weeks after surgery.

  3. the Duration of ICU Stay

    Time frame: upto 2 weeks after surgery

    Participants will be followed for the duration of ICU stay, an expected average of 2 weeks after surgery.

  4. the Duration of Hospital Stay

    Time frame: upto 1 month after surgery

    Participants will be followed for the duration of hospital stay, an expected average of 1 month after surgery.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 9, 2011
Registry last updated
Sep 26, 2013

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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