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

Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03141385
Collaborator
(none)
130
Enrollment
1
Location
2
Arms
13.7
Actual Duration (Months)
9.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: remote ischemic preconditioning
  • Other: Control
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Renal Effects of Remote Ischemic Preconditioning in Patients After Total Arch Replacement
Actual Study Start Date :
Apr 7, 2017
Actual Primary Completion Date :
May 1, 2018
Actual Study Completion Date :
May 30, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of AKI within the 7 days after the surgery [Within 7 days after the surgery]

    AKI defined by KDIGO criteria

Secondary Outcome Measures

  1. Incidence of severe AKI (stage 2 and stage 3) [Within 7 days after the surgery]

    severity defined by KDIGO criteria

  2. Renal replacement therapy [Within 30 days after the surgery]

    the requirement for RRT during index hospital stay

  3. Mechanical ventilation duration [Within 30 days after the surgery]

    duration of mechanical ventilation in the intensive care unit

  4. Length of intensive care unit stay [Within 30 days after the surgery]

    length of stay on the intensive care unit

  5. In-hospital death [Within 30 days after the surgery]

    in-hospital all-cause death

  6. Stroke [Within 30 days after the surgery]

    new onset stroke during index hospital stay

  7. Paraplegia [Within 30 days after the surgery]

    impairment in motor or sensory function of the lower extremities during index hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC Beijing China

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guyan Wang, The Chief of Infection-Control Department, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier:
NCT03141385
Other Study ID Numbers:
  • FW2016-F09
First Posted:
May 5, 2017
Last Update Posted:
Jul 11, 2018
Last Verified:
Jul 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Acute Kidney Injury

Study Results

No Results Posted as of Jul 11, 2018