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

Primary Purpose

Acute Kidney Injury, Dialysis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
remote ischemic preconditioning
Control
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

RIPC intervention

Control

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

Incidence of AKI within the 7 days after the surgery
AKI defined by KDIGO criteria

Secondary Outcome Measures

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

Full Information

First Posted
May 3, 2017
Last Updated
July 10, 2018
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03141385
Brief Title
Renal Effects of RIPC in Patients After Total Arch Replacement
Acronym
RenRIPC-TAR
Official Title
Renal Effects of Remote Ischemic Preconditioning in Patients After Total Arch Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 7, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Dialysis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIPC intervention
Arm Type
Experimental
Arm Description
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)
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
remote ischemic preconditioning
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of AKI within the 7 days after the surgery
Description
AKI defined by KDIGO criteria
Time Frame
Within 7 days after the surgery
Secondary Outcome Measure Information:
Title
Incidence of severe AKI (stage 2 and stage 3)
Description
severity defined by KDIGO criteria
Time Frame
Within 7 days after the surgery
Title
Renal replacement therapy
Description
the requirement for RRT during index hospital stay
Time Frame
Within 30 days after the surgery
Title
Mechanical ventilation duration
Description
duration of mechanical ventilation in the intensive care unit
Time Frame
Within 30 days after the surgery
Title
Length of intensive care unit stay
Description
length of stay on the intensive care unit
Time Frame
Within 30 days after the surgery
Title
In-hospital death
Description
in-hospital all-cause death
Time Frame
Within 30 days after the surgery
Title
Stroke
Description
new onset stroke during index hospital stay
Time Frame
Within 30 days after the surgery
Title
Paraplegia
Description
impairment in motor or sensory function of the lower extremities during index hospital stay
Time Frame
Within 30 days after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guyan Wang, PhD
Organizational Affiliation
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32646379
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.
Results Reference
derived
PubMed Identifier
30896603
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.
Results Reference
derived

Learn more about this trial

Renal Effects of RIPC in Patients After Total Arch Replacement

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