N/A
N=121
Remote Ischemic Conditioning (RIC) in Recipients of Brain Death Donor Livers - A Feasibility and Safety Study
Liver Failure · Carcinoma, Hepatocellular
Bottom Line
View on ClinicalTrials.gov: NCT02635347 ↗Enrolled (actual)
121
Serious AEs
1.1%
Results posted
Aug 2019
Primary outcome: Primary: Percentage of Participants Completing Entire Intervention Protocol — 70.96 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Remote Ischemic Conditioning (RIC) (Procedure); Pneumatic tourniquet (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Completing Entire Intervention Protocol |
70.96 | — |
| SECONDARY Intervention-related Pain Score |
5 | — |
| SECONDARY Withdrawal of Consent Due to Pain |
6; 0 | — |
| SECONDARY Percentage of Participants Who Developed Early Allograft Dysfunction (EAD) |
23.3; 39.68 | — |
| SECONDARY Percentage of Participants Who Developed Prolonged Respiratory Insufficiency (PRI) |
33.3; 28.57 | — |
| SECONDARY Percentage of Participants Who Developed Acute Kidney Injury (AKI) Stages 2 or 3 |
20.0; 25.86 | — |
| SECONDARY Time to Dialysis Discontinuation |
2; 15.5 | — |
| SECONDARY Presence of Clavien-Dindo Grade IIIb or Higher Complications |
51.1; 47.62 | — |
| SECONDARY Clavien-Dindo Grade IIIb or Higher - Number of Complications |
1; 0 | — |
| SECONDARY Intensive Care Unit (ICU) Length of Stay (LOS) |
3.5; 4 | — |
| SECONDARY Hospital LOS |
13; 10 | — |
| SECONDARY Liver Allograft Survival |
90; 98.41 | — |
| SECONDARY Patient Survival |
90.32; 98.41 | — |
| SECONDARY Number of Subjects Not Completing Intervention Protocol |
9 | — |
Summary
This study will assess the feasibility of lower limb-ischemia induced Remote Ischemic Conditioning (RIC) in the perioperative period before, during, and after Orthotopic Liver Transplantation (OLT). Remote ischemic conditioning will consist of 3 cycles of 5 minutes of lower limb ischemia induced via a mid-thigh pneumatic tourniquet, followed by 5 minutes of reperfusion. Interventions will take place after anesthesia induction but before surgery, at the completion of the procedure, and on the mornings of post-operative days 1-4.
Eligibility Criteria
Inclusion Criteria
- Adults (> 18 years of age) with acute and chronic liver failure requiring liver transplants or patients undergoing transplantation for hepatocellular carcinoma.
- Both sexes
- Written consent to participate in the study
Exclusion Criteria
- 45
- Pregnant patients
- Patients in whom complete lower extremity ischemia is not achieved despite maximum tourniquet inflation to 250 mmHg during the first intervention
- Patients with lower extremity paralysis
Data sourced from ClinicalTrials.gov (NCT02635347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.