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

Primary Purpose

Dissection of Thoracic Aorta

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

recombinant human erythropoietin

saline

About this trial

This is an interventional prevention trial for Dissection of Thoracic Aorta

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Gangnam severance hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Saline group

erythropoietin group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of Acute Kidney Injury Based on RIFLE Criteria

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

Incidence of Acute Kidney Injury Based on RIFLE Criteria

Secondary Outcome Measures

Mortality

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

the Duration of Mechanical Ventilation

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

the Duration of ICU Stay

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

the Duration of Hospital Stay

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

Full Information

NCT ID

NCT01369732

First Posted

June 3, 2011

Last Updated

July 24, 2013

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01369732

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dissection of Thoracic Aorta

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Saline group

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

erythropoietin group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

recombinant human erythropoietin

Other Intervention Name(s)

epocaine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

saline

Other Intervention Name(s)

normal saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of Acute Kidney Injury Based on RIFLE Criteria

Description

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

Time Frame

upto 7 days after surgery

Title

Incidence of Acute Kidney Injury Based on RIFLE Criteria

Time Frame

upto 7 days after surgery

Secondary Outcome Measure Information:

Title

Mortality

Description

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

Time Frame

upto 1 month after surgery

Title

the Duration of Mechanical Ventilation

Description

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

Time Frame

upto 2 weeks after surgery

Title

the Duration of ICU Stay

Description

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

Time Frame

upto 2 weeks after surgery

Title

the Duration of Hospital Stay

Description

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

Time Frame

upto 1 month after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yon Hee Shim

Organizational Affiliation

Yonsei University

Official's Role

Study Director

Facility Information:

Facility Name

Gangnam severance hospital

City

Seoul

ZIP/Postal Code

135-720

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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