NCT04647370

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

9 months

First QC Date

September 27, 2020

Last Update Submit

April 16, 2021

Conditions

Ischemia Reperfusion Injury

Outcome Measures

Primary Outcomes (1)

  • liver function test

    Direct Bilirubin

    3 postoperative days

Study Arms (2)

Remote ischemic preconditioning

ACTIVE COMPARATOR
Procedure: remote ischemic preconditioning

Sham remote ischemic preconditioning

SHAM COMPARATOR
Procedure: Sham remote ischemic preconditioning

Interventions

remote ischemic preconditioningPROCEDURE

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

Remote ischemic preconditioning
Sham remote ischemic preconditioningPROCEDURE

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).

Sham remote ischemic preconditioning

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University hospital

Asyut, Asyut Governorate, 11111, Egypt

RECRUITING

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor of anesthesia

Study Record Dates

First Submitted

September 27, 2020

First Posted

November 30, 2020

Study Start

April 1, 2021

Primary Completion

January 1, 2022

Study Completion

March 1, 2022

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)