Clinical trial NCT03141385: Renal Effects of RIPC in Patients After Total Arch Replacement
Official title: Renal Effects of Remote Ischemic Preconditioning in Patients After Total Arch Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Dialysis
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of AKI within the 7 days after the surgery
timeFrame: Within 7 days after the surgery
Secondary outcomes:
measure: Incidence of severe AKI (stage 2 and stage 3)
timeFrame: Within 7 days after the surgery
measure: Renal replacement therapy
timeFrame: Within 30 days after the surgery
measure: Mechanical ventilation duration
timeFrame: Within 30 days after the surgery
measure: Length of intensive care unit stay
timeFrame: Within 30 days after the surgery
measure: In-hospital death
timeFrame: Within 30 days after the surgery
measure: Stroke
timeFrame: Within 30 days after the surgery
measure: Paraplegia
timeFrame: Within 30 days after the surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC
Study officials:
affiliation: State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC, Beijing, China
name: Guyan Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen Y, Wang G, Zhou H, Yang L, Zhang C, Yang X, Lei G. 90 days impacts of remote ischemic preconditioning on patients undergoing open total aortic arch replacement: a post-hoc analysis of previous trial. BMC Anesthesiol. 2020 Jul 9;20(1):169. doi: 10.1186/s12871-020-01085-9.
citation: Zhou H, Yang L, Wang G, Zhang C, Fang Z, Lei G, Shi S, Li J. Remote Ischemic Preconditioning Prevents Postoperative Acute Kidney Injury After Open Total Aortic Arch Replacement: A Double-Blind, Randomized, Sham-Controlled Trial. Anesth Analg. 2019 Jul;129(1):287-293. doi: 10.1213/ANE.0000000000004127.