Remote Ischemic Preconditioning in Cardiac Surgery

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

Aim of the work :

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

Study Overview

• Status: Recruiting
• Conditions: Ischemia Reperfusion Injury
• Intervention / Treatment: Procedure: remote ischemic preconditioning; Procedure: Sham remote ischemic preconditioning

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Asyut Governorate
    • Assiut, Asyut Governorate, Egypt, 11111
      • Recruiting
      • Assiut University Hospital
      • Contact: Mostafa Abbas, M.D.; Phone Number: 01003060187; Email: mostafasamy@aun.edu.eg
      • Principal Investigator: Mostafa S Abbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
liver function test	Direct Bilirubin	3 postoperative days

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: September 27, 2020
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (Actual): November 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 16, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Ischemia; Reperfusion Injury
• Other Study ID Numbers: Ischemic Preconditioning

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