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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04433468
• Other study ID #: 2020RIPC
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: June 2022
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

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.

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The incidence of postoperative delirium	CAM score greater than 22	within 7 days after operation