Study on the Protective Effect of RIPC in Patients Undergoing Cardiac Surgery.

To observe the effect of RIPC on the function of vital organs after cardiac surgery, and to explore its possible mechanism.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Device: RIPC

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • 180 Fenglin Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with aortic valve, mitral valve, tricuspid valve, ascending aortic disease and coronary atherosclerosis who were admitted to hospital for elective valve repair, replacement, artificial vascular replacement or coronary artery bypass grafting.
• age 18-80 years old.
• No restriction on gender.
• ASA grade II~III.
• NYHAII~III level.
• the patient or his family member has signed the informed consent form for the clinical trial

Exclusion Criteria:

• those who are disabled in the selected test.
• less than 5 years of education.
• The preoperative left ventricular ejection fraction ((LVEF)) was less than 40%.
• Myocardial infarction occurred in nearly one month.
• malignant tumor, hematological disease, severe liver and kidney dysfunction, recent severe infection, etc.
• History of nervous system, immune system and mental illness.
• recent operation history of heart, brain, lung, liver, kidney and other important organs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Active Comparator: RIPC	Device: RIPC; The tourniquet attached to the upper limb was inflated and blocked for 5 minutes, then deflated for 5 minutes to restore blood flow and induce ischemic preconditioning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of acute renal injury after operation	According to the (KDIGO) guidelines for improving the prognosis of renal disease	within 7 days after operation
The incidence of postoperative delirium	CAM score greater than 22	within 7 days after operation

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2020RIPC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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