Back to resultsRemote Ischemic Preconditioning in Cardiac Surgery
Primary Purpose
Ischemia Reperfusion Injury
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
remote ischemic preconditioning
Sham remote ischemic preconditioning
Sponsored by
About this trial
This is an interventional prevention trial for Ischemia Reperfusion Injury
Eligibility Criteria
Inclusion Criteria:
- Being candidate for on-pump cardiac surgery.
- Willing to participate in the study
- Ages eligible for the study: 18 to 70 years.
- Gender eligible for the study : both
Exclusion Criteria:
- Patient refusal.
- Known cause of possible liver function disturbances that includes right heart failure, acute inflammation of gallbladder or any other complication of gallstone disease.
- Active viral and non viral hepatitis.
- Pregnant women.
- History of peripheral nerve disease or peripheral vascular disease of the extremities
Sites / Locations
- Assiut University hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Remote ischemic preconditioning
Sham remote ischemic preconditioning
Arm Description
Outcomes
Primary Outcome Measures
liver function test
Direct Bilirubin
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04647370
Brief Title
Remote Ischemic Preconditioning in Cardiac Surgery
Official Title
Implications of Remote Ischemic Preconditioning on Liver Function in Adults Undergoing Cardiac Surgery: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia Reperfusion Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remote ischemic preconditioning
Arm Type
Active Comparator
Arm Title
Sham remote ischemic preconditioning
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
remote ischemic preconditioning
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Sham remote ischemic preconditioning
Intervention Description
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).
Primary Outcome Measure Information:
Title
liver function test
Description
Direct Bilirubin
Time Frame
3 postoperative days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being candidate for on-pump cardiac surgery.
Willing to participate in the study
Ages eligible for the study: 18 to 70 years.
Gender eligible for the study : both
Exclusion Criteria:
Patient refusal.
Known cause of possible liver function disturbances that includes right heart failure, acute inflammation of gallbladder or any other complication of gallstone disease.
Active viral and non viral hepatitis.
Pregnant women.
History of peripheral nerve disease or peripheral vascular disease of the extremities
Facility Information:
Facility Name
Assiut University hospital
City
Assiut
State/Province
Asyut Governorate
ZIP/Postal Code
11111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mostafa Abbas, M.D.
Phone
01003060187
Email
mostafasamy@aun.edu.eg
First Name & Middle Initial & Last Name & Degree
Mostafa S Abbas
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Remote Ischemic Preconditioning in Cardiac Surgery
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