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NCT04647370 Clinical Trial

Remote Ischemic Preconditioning in Cardiac Surgery

Ischemia Reperfusion Injury Clinical Trial

Official title:
Implications of Remote Ischemic Preconditioning on Liver Function in Adults Undergoing Cardiac Surgery: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04647370
Other study ID # Ischemic Preconditioning
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date March 2022

Study information
Verified date April 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim of the work : Evaluation of the role of Remote Ischemic Preconditioning (RIP) on liver function in patients undergoing on-pump cardiac surgery.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date March 2022
Est. primary completion date January 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Being candidate for on-pump cardiac surgery. 2. Willing to participate in the study 3. Ages eligible for the study: 18 to 70 years. 4. Gender eligible for the study : both Exclusion Criteria: 1. Patient refusal. 2. Known cause of possible liver function disturbances that includes right heart failure, acute inflammation of gallbladder or any other complication of gallstone disease. 3. Active viral and non viral hepatitis. 4. Pregnant women. 5. History of peripheral nerve disease or peripheral vascular disease of the extremities

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• remote ischemic preconditioning
3 cycles of 5-minutes inflation of a blood pressure cuff to 200mmHg (or at least to a pressure 50mm Hg higher than the systolic arterial pressure) to one upper arm, followed by5-minutes reperfusion with the cuff deflated
• Sham remote ischemic preconditioning
3cycles of upper limb pseudo ischemia (low pressure, 5-minutes blood pressure cuff inflation to a pressure of 20 mm Hg and 5-minutes cuff deflation).

Locations
Country Name City State
Egypt Assiut University hospital Assiut Asyut Governorate

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary liver function test Direct Bilirubin 3 postoperative days
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