Study design of the DAS-OLT trial: a randomized controlled trial to evaluate the impact of dexmedetomidine on early allograft dysfunction following liver transplantation

This study aimed to verify the hypothesis that the application of dexmedetomidine during the perioperative period of liver transplantation can reduce the incidence of EAD and primary graft non-function (PNF). At the same time, the effects of dexm edetomidine application on perioperative renal function and lung function were studied.MethodsThis is a prospective, single-center, randomized, parallel-group study. Two hundred participants (18 –65 years) scheduled to undergo liver transplantation under general anesthesia will be included in this study. For participants in the treatment group, a loading dose of DEX will be given after induction of anesthesia (1 μg/kg over 10 min) followed by a continuous infusion (0.5 μg/kg /h) until the end of surgery. For participants in the placebo group, an equal volume loading dose of 0.9% saline will be given after the induction of anesthesia followed by an equal volume continuous infusion until the end of surgery. All other supplements, e.g., opioids, sedatives, and muscle relaxant , will be identical in both arms and administered according to routine clinical practice.DiscussionThe present trial will examine whether DEX confers organoprotective effects in the liver, in terms of reducing the incidence of EAD and PNF in orthotopic liver transplantation recipients.Trial registrationClinicalTrials.gov NCT03770130. Registered on 10 December 2018.https://clinicaltrials.gov/ct2/show/NCT03770130
Source: Trials - Category: Research Source Type: clinical trials