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

NCT01369732 | Completed Phase 4 Results

• 1 other identifier: 3-2011-0086
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Dissection of Thoracic Aorta

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Mortality

  upto 1 month after surgery

• the Duration of Mechanical Ventilation

  upto 2 weeks after surgery

• the Duration of ICU Stay

  upto 2 weeks after surgery

• the Duration of Hospital Stay

  upto 1 month after surgery

Study Arms (2)

Saline group

PLACEBO COMPARATOR

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

Drug: saline

erythropoietin group

EXPERIMENTAL

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

Drug: recombinant human erythropoietin

Interventions

recombinant human erythropoietin DRUG

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

Also known as: epocaine

erythropoietin group

saline DRUG

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

Also known as: normal saline

Saline group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Gangnam severance hospital

Seoul, 135-720, South Korea

Location

MeSH Terms

Conditions

Dissection, Thoracic Aorta

Interventions

Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Aortic Dissection; Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Yon Hee Shim
• Organization: Yonsei University College of Medicine

tren125@yuhs.ac

82220193547

Study Officials

• Yon Hee Shim

  Yonsei University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: June 9, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: September 26, 2013
• Results First Posted: September 26, 2013

Record last verified: 2013-07

Locations

KR (1)