Remote Ischemic Preconditioning in Cardiac Surgery

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04647370
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11
• Patients Per Site Per Month: 8.2

Study Details

Study Description

Brief Summary

Aim of the work :

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

Condition or Disease	Intervention/Treatment	Phase
Ischemia Reperfusion Injury	Procedure: remote ischemic preconditioning; Procedure: Sham remote ischemic preconditioning	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Implications of Remote Ischemic Preconditioning on Liver Function in Adults Undergoing Cardiac Surgery: Randomized Controlled Trial
• Actual Study Start Date: Apr 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Remote ischemic preconditioning	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 Comparator: Sham remote ischemic preconditioning	Procedure: 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).

Outcome Measures

Primary Outcome Measures

1. liver function test [3 postoperative days]

   Direct Bilirubin

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University hospital	Assiut	Asyut Governorate	Egypt	11111

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mostafa Samy Abbas, associate professor of anesthesia, Assiut University
• ClinicalTrials.gov Identifier: NCT04647370
• Other Study ID Numbers: Ischemic Preconditioning
• First Posted: Nov 30, 2020
• Last Update Posted: Apr 20, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Reperfusion Injury; Ischemia

Study Results

No Results Posted as of Apr 20, 2021