Clinical trial · Interventional
Remote Ischemic Conditioning (RIC) in Recipients of Brain Death Donor Livers - A Feasibility and Safety Study
NCT02635347CI-TRIAL-00040156completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Failure | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pneumatic tourniquet | Device | — | UNRESOLVED |
| Remote Ischemic Conditioning (RIC) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Remote Ischemic Conditioning (RIC) group
- description
- Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC
- interventionNames
- Procedure: Remote Ischemic Conditioning (RIC)
- Device: Pneumatic tourniquet
Primary outcomes (1)
- measure
- Percentage of Participants Completing Entire Intervention Protocol
- timeFrame
- Pre-op - Post-op day 4
- description
- Proportion of enrolled liver recipients that complete all 6 remote ischemic conditioning (RIC) interventions.
Secondary outcomes (13)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: * \< 18 years of age * Recipients of split livers * Retransplantation * Recipients of livers combined with other organs * Recipients of livers from cardiac death donors * Lower extremity amputees * History of peripheral vascular disease * Patients taking sulfonylurea anti-diabetic agents at the time of transplant * Patients taking nitrates at the time of transplant * Body mass index \> 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
References
Publications (25)
- BACKGROUNDParikh A, Washburn KW, Matsuoka L, Pandit U, Kim JE, Almeda J, Mora-Esteves C, Halff G, Genyk Y, Holland B, Wilson DJ, Sher L, Koneru B. A multicenter study of 30 days complications after deceased donor liver transplantation in the model for end-stage liver disease score era. Liver Transpl. 2015 Sep;21(9):1160-8. doi: 10.1002/lt.24181. PMID 25991395
- BACKGROUNDHuang CT, Lin HC, Chang SC, Lee WC. Pre-operative risk factors predict post-operative respiratory failure after liver transplantation. PLoS One. 2011;6(8):e22689. doi: 10.1371/journal.pone.0022689. Epub 2011 Aug 1. PMID 21829646
- BACKGROUNDLevesque E, Hoti E, Azoulay D, Honore I, Guignard B, Vibert E, Ichai P, Antoun F, Saliba F, Samuel D. Pulmonary complications after elective liver transplantation-incidence, risk factors, and outcome. Transplantation. 2012 Sep 15;94(5):532-8. doi: 10.1097/TP.0b013e31825c1d41. PMID 22885879
- BACKGROUNDGracey DR, Divertie MB, Didier EP. Preoperative pulmonary preparation of patients with chronic obstructive pulmonary disease: a prospective study. Chest. 1979 Aug;76(2):123-9. doi: 10.1378/chest.76.2.123. PMID 456049
- BACKGROUNDSvensson LG, Hess KR, Coselli JS, Safi HJ, Crawford ES. A prospective study of respiratory failure after high-risk surgery on the thoracoabdominal aorta. J Vasc Surg. 1991 Sep;14(3):271-82. PMID 1880835
- BACKGROUNDArozullah AM, Daley J, Henderson WG, Khuri SF. Multifactorial risk index for predicting postoperative respiratory failure in men after major noncardiac surgery. The National Veterans Administration Surgical Quality Improvement Program. Ann Surg. 2000 Aug;232(2):242-53. doi: 10.1097/00000658-200008000-00015. PMID 10903604
- BACKGROUNDHilmi IA, Damian D, Al-Khafaji A, Planinsic R, Boucek C, Sakai T, Chang CC, Kellum JA. Acute kidney injury following orthotopic liver transplantation: incidence, risk factors, and effects on patient and graft outcomes. Br J Anaesth. 2015 Jun;114(6):919-26. doi: 10.1093/bja/aeu556. Epub 2015 Feb 10.