The Effect of Remote Ischemic Preconditioning on Ischemia/Reperfusion Injury in a Liver Transplant Recipient
- Conditions
- Ischemia Reperfusion InjuryLiver Transplant; Complications
- Interventions
- Other: non remote ischemic preconditioning (non-rIC)Procedure: remote ischemic preconditioning (rIC)
- Registration Number
- NCT03758352
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief Summary
Ischemia and reperfusion injury is unavoidable during a liver transplantation. Remote ischemic preconditioning, a safe and feasible method, has previously been shown to reduce ischemia and reperfusion injury. In the transplantation setting, focus of remote ischemic preconditioning has been on the donor. However, preconditioning of the recipient may be a better approach due to the mechanisms by which ischemic preconditioning protects against ischemia and reperfusion injury.
The aim of this randomised, double-blinded clinical trial is to biochemically assess the liver function after application of remote ischemic preconditioning on the recipient.
- Detailed Description
Background The use of solid organ transplantation, including liver transplantation, is the golden standard for many end-stage solid organ diseases. Ischemia and reperfusion injury is unavoidable during a liver transplantation. Remote ischemic preconditioning, a safe and feasible method, has previously been shown to reduce ischemia and reperfusion injury. This may have a similar effect in a liver transplantation setting. In the transplantation setting, focus of remote ischemic preconditioning has been on the donor. However, preconditioning of the recipient may be a better approach due to the mechanisms by which ischemic preconditioning protects against ischemia and reperfusion injury.
The aim of this randomised, double-blinded clinical trial is to biochemically assess the liver function after application of remote ischemic preconditioning on the recipient.
Methods 52 patients undergoing a liver transplantation, included in accordance to the inclusion criteria, will be allocated to an intervention group (rIC-group) and compared to a retrospective non-intervention control group (non-rIC group) consisting of 52 patients. Patients in the non-intervention group will also be included in accordance to the inclusion criteria. Within two hours before surgery, patients in the intervention group will be subjected to four rounds of five-minute inflations and five-minute deflations of a pneumatic tourniquet applied on the right leg.
Follow-up time will be 30 days.
Measurements The aim of this trial is to assess the effect of remote ischemic preconditioning on the extent of liver injury and inflammation as a result of ischemia and reperfusion injury. Assessment will be done by measurement of biomarkers relevant to liver function and liver injury.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Patients undergoing liver transplantation
- Patients aged 18 or above
- Patients who have given an informed consent
- Patients undergoing re-transplantation.
- Patients who do not or cannot give an informed consent.
- Patients who have undergone surgery six weeks prior to liver transplantation.
- Patients with known peripheral vascular disease.
- Patients with an infection localized to the area of rIC-intervention
- Patients with at a high risk or with previous history of multiple thrombo-embolic diseases.
- Patients undergoing active immunosuppressive therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group (non-rIC) non remote ischemic preconditioning (non-rIC) The control group will be a retrospective group, who have undergone a liver transplantation and meet the inclusion criteria. intervention group (rIC) remote ischemic preconditioning (rIC) The rIC procedure will be applied on seated patients, who have been resting for at least five minutes. The active rIC procedure consists of four five-minute inflations of a pneumatic tourniquet to 100 mmHg above the patient's systolic blood pressure separated by five-minute periods of complete deflation. Placement of the pneumatic tourniquet will be unilaterally on a lower limb (right thigh)
- Primary Outcome Measures
Name Time Method Post-operative change in ALT Day 0-4 Extent of liver injury measured as change in ALT postoperative from day zero to day four .
- Secondary Outcome Measures
Name Time Method Post-operative change in Bilirubin Day 0-4 Serological markers of liver function
Post-operative change in Aspartate Amonitransferase Day 0-4 Serological markers of liver function
Post-operative change in Alkaline Phosphatase Day 0-4 Serological markers of liver function
Post-operative change in International Normalised Ratio Day 0-4 Serological markers of liver function