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

Phase 4

Completed

• Conditions: Dissection of Thoracic Aorta
• Interventions: Drug: saline; Drug: recombinant human erythropoietin

• Registration Number: NCT01369732
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-03
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-09
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-07
• Results First Submitted: 2013-07-10
• Results First Submitted QC: 2013-07-24
• Last Update Submitted: 2013-07-24
• Results First Posted: 2013-09-26
• Last Update Posted: 2013-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline group	saline	We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
erythropoietin group	recombinant human erythropoietin	We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.

Primary Outcome Measures

Name	Time	Method
Incidence of Acute Kidney Injury Based on RIFLE Criteria	upto 7 days after surgery

Secondary Outcome Measures

Name	Time	Method
the Duration of ICU Stay	upto 2 weeks after surgery	Participants will be followed for the duration of ICU stay, an expected average of 2 weeks after surgery.
Mortality	upto 1 month after surgery	Participants will be followed for the mortality, an expected average of 1 month after surgery.
the Duration of Mechanical Ventilation	upto 2 weeks after surgery	Participants will be followed for the duration of mechanical ventilation, an expected average of 2 weeks after surgery.
the Duration of Hospital Stay	upto 1 month after surgery	Participants will be followed for the duration of hospital stay, an expected average of 1 month after surgery.

Trial Locations

Locations (1)

Gangnam severance hospital; 🇰🇷 Seoul, Korea, Republic of