Mode
Text Size
Log in / Sign up
Phase 4 N=66 Randomized Quadruple-blind Prevention

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

Dissection of Thoracic Aorta

Enrolled (actual)
66
Serious AEs
Results posted
Sep 2013
Primary outcome: Primary: Incidence of Acute Kidney Injury Based on RIFLE Criteria

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
recombinant human erythropoietin (Drug); saline (Drug)
Age
Adult, Older Adult · 20+ yrs
Sex
All
Sponsor
Yonsei University
Primary completion
Jan 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Incidence of Acute Kidney Injury Based on RIFLE Criteria
18; 18
PRIMARY
Incidence of Acute Kidney Injury Based on RIFLE Criteria
18; 18
SECONDARY
Mortality
SECONDARY
the Duration of Mechanical Ventilation
SECONDARY
the Duration of ICU Stay
SECONDARY
the Duration of Hospital Stay

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01369732). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search