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Clinical Trials/NCT03141385
NCT03141385
Completed
Not Applicable

Renal Effects of Remote Ischemic Preconditioning in Patients After Total Arch Replacement

Chinese Academy of Medical Sciences, Fuwai Hospital1 site in 1 country130 target enrollmentApril 7, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Enrollment
130
Locations
1
Primary Endpoint
Incidence of AKI within the 7 days after the surgery
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.

Detailed Description

Acute kidney injury (AKI) is a well-recognized complication after cardio-thoracic surgeries and is associated with increased morbidity and mortality. Total arch replacement is reported with a relatively high incidence of post-operative AKI. In addition, few effective preventive or therapeutic interventions for AKI have been identified. A number of studies have now addressed renal protection as a primary outcome following RIPC. Because the mechanism of I/R injury are similar to those proposed for AKI after CPB, the purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.

Registry
clinicaltrials.gov
Start Date
April 7, 2017
End Date
May 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Responsible Party
Principal Investigator
Principal Investigator

Guyan Wang

The Chief of Infection-Control Department

Chinese Academy of Medical Sciences, Fuwai Hospital

Eligibility Criteria

Inclusion Criteria

  • patients scheduled for total arch replacement
  • written informed consent

Exclusion Criteria

  • pre-existing AKI
  • peripheral vascular disease affecting the upper limbs
  • hybrid total arch replacement
  • the history of kidney transplantation

Outcomes

Primary Outcomes

Incidence of AKI within the 7 days after the surgery

Time Frame: Within 7 days after the surgery

AKI defined by KDIGO criteria

Secondary Outcomes

  • Renal replacement therapy(Within 30 days after the surgery)
  • Length of intensive care unit stay(Within 30 days after the surgery)
  • Incidence of severe AKI (stage 2 and stage 3)(Within 7 days after the surgery)
  • In-hospital death(Within 30 days after the surgery)
  • Stroke(Within 30 days after the surgery)
  • Paraplegia(Within 30 days after the surgery)
  • Mechanical ventilation duration(Within 30 days after the surgery)

Study Sites (1)

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