NCT06312098

Brief Summary

Liver transplant surgery is one of the treatments provided to patients suffering from end-stage liver disease, and has a successful treatment prognosis. However, it is clear that patient management before, during, and after surgery is a difficult task for medical staff due to the complex clinical and pathological problems of end-stage liver disease. Moreover, the complex surgical technique of the liver transplant surgery itself and the severe hemodynamic fluctuations and multi-organ dysfunction that patients experience during the surgery have been shown to have a tremendous impact on the patient's prognosis after surgery. A study on which clinical, laboratory, and hemodynamic factors experienced by patients during the perioperative period, including before, during, and after surgery, affect the survival rate of patients and transplanted organs. will definitely be helpful in the treatment of patients suffering from end-stage liver disease.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
533

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 8, 2024

Last Update Submit

March 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of postreperfusion syndrome

    mean blood pressure decreases by 30% based on the value on preoperative day

    during surgery

Study Arms (2)

no-remote ischemic preconditioning group

patients who did not receive remote ischemic preconditioning

paired remote ischemic preconditioning group

patients who receive remote ischemic preconditioning

Other: remote ischemic preconditioning (RIPC)

Interventions

After induction of anesthesia, the paired RIPC group took the RIPC intervention on the upper arm in the lateral position. The RIPC intervention was applied using a manual cuff inflator, which consisted of three cycles of 5-min inflation of the blood pressure cuff (to 250 mmHg, or to 50 mmHg higher than the preoperative SBP), followed by 5-min deflation of the cuff. In the no-RIPC group, a blood pressure cuff was also applied on the upper arm but was not inflated.

paired remote ischemic preconditioning group

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Data from adult patients undergoing elective living donor liver transplantation at Seoul St. Mary's Hospital were retrospectively collected with the electronic medical record system.

You may qualify if:

  • adults
  • elective surgery
  • American Society of Anesthesiologists (ASA) physical status classification system I, II, III

You may not qualify if:

  • American Society of Anesthesiologists (ASA) physical status classification system IV, V

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 8, 2024

First Posted

March 15, 2024

Study Start

April 1, 2024

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

March 18, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

The datasets used and/or analyzed during this study are available from the corresponding author on reasonable request.