Renal Effects of RIPC in Patients After Total Arch Replacement (RenRIPC-TAR)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Dialysis
• Intervention / Treatment: Other: remote ischemic preconditioning; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIPC intervention; Remote ischemic preconditioning (RIPC) will be induced after the general anesthesia prior to the cardiopulmonary bypass by four cycles of right limber ischemia (5-min blood pressure cuff inflation to a pressure of 200mmHg or a pressure that is 50 mmHg higher than SAP and 5-min cuff deflation)	Other: remote ischemic preconditioning; Remote ischemic preconditioning (RIPC) will be induced after the general anesthesia prior to the cardiopulmonary bypass by four cycles of right limber ischemia (5-min blood pressure cuff inflation to a pressure of 200mmHg or a pressure that is 50 mmHg higher than SAP and 5-min cuff deflation)
Sham Comparator: Control; Four cycles of right upper limb pseudo ischemia and reperfusion, which will be induced by 5-minute blood pressure cuff inflation to a low pressure of 20 mmHg followed by 5-minute cuff deflated.	Other: Control; Four cycles of right upper limb pseudo ischemia and reperfusion, which will be induced by 5-minute blood pressure cuff inflation to a low pressure of 20 mmHg followed by 5-minute cuff deflated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AKI within the 7 days after the surgery	AKI defined by KDIGO criteria	Within 7 days after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of severe AKI (stage 2 and stage 3)	severity defined by KDIGO criteria	Within 7 days after the surgery
Renal replacement therapy	the requirement for RRT during index hospital stay	Within 30 days after the surgery
Mechanical ventilation duration	duration of mechanical ventilation in the intensive care unit	Within 30 days after the surgery
Length of intensive care unit stay	length of stay on the intensive care unit	Within 30 days after the surgery
In-hospital death	in-hospital all-cause death	Within 30 days after the surgery
Stroke	new onset stroke during index hospital stay	Within 30 days after the surgery
Paraplegia	impairment in motor or sensory function of the lower extremities during index hospital stay	Within 30 days after the surgery

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Investigators: Principal Investigator: Guyan Wang, PhD, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC, Beijing, China

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2017
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: FW2016-F09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No