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

NCT ID: NCT01369732

Last Updated: 2013-09-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Dissection of Thoracic Aorta

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Saline group

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

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

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

erythropoietin group

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

Group Type EXPERIMENTAL

recombinant human erythropoietin

Intervention Type DRUG

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

Interventions

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recombinant human erythropoietin

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

Intervention Type DRUG

saline

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

Intervention Type DRUG

Other Intervention Names

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epocaine normal saline

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yon Hee Shim

Role: STUDY_DIRECTOR

Yonsei University

Locations

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Gangnam severance hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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3-2011-0086

Identifier Type: -

Identifier Source: org_study_id