Liver Transplant; Complications Clinical Trial
Official title:
The Effect of Remote Ischemic Preconditioning on Ischemia/Reperfusion Injury in a Liver Transplant Recipient (TRSPLNT) - A Randomized, Controlled, Double-blinded Clinical Trial.
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.
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.
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