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

Dissection of Thoracic Aorta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369732
• Other study ID #: 3-2011-0086
• Status: Completed
• Phase: Phase 4
• First received: June 3, 2011
• Last updated: July 24, 2013
• Start date: May 2011
• Est. completion date: January 2013

Study information

• Verified date: July 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Dissection of Thoracic Aorta
• Heart Arrest

Intervention

Drug:
• recombinant human erythropoietin
We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
• saline
We administrate the saline single bolus (5ml intravenously) 30 min before the commencement of ischemia.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Incidence of Acute Kidney Injury Based on RIFLE Criteria		upto 7 days after surgery	No
Secondary	Mortality	Participants will be followed for the mortality, an expected average of 1 month after surgery.	upto 1 month after surgery	No
Secondary	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	No
Secondary	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	No
Secondary	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	No