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

Prevention of Acute Kidney Injury by Erythropoietin in Patients Undergoing 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.

Study Overview

• Status: Completed
• Conditions: Dissection of Thoracic Aorta
• Intervention / Treatment: Drug: saline; Drug: recombinant human erythropoietin

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-720
    • Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: epocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	upto 7 days after surgery
Incidence of Acute Kidney Injury Based on RIFLE Criteria		upto 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Participants will be followed for the mortality, an expected average of 1 month after surgery.	upto 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.	upto 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.	upto 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.	upto 1 month after surgery

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Study Director: Yon Hee Shim, Yonsei University

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: June 3, 2011
• First Submitted That Met QC Criteria: June 8, 2011
• First Posted (Estimate): June 9, 2011

Study Record Updates

• Last Update Posted (Estimate): September 26, 2013
• Last Update Submitted That Met QC Criteria: July 24, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury; Heart Arrest; Hematinics; Epoetin Alfa
• Other Study ID Numbers: 3-2011-0086