NCT03770130

Dexmedetomidine and Liver Transplantation

Completed EARLY_PHASE1 Last updated 21 August 2023

What this trial tests

EARLY_PHASE1 trial testing Dexmedetomidine in Dexmedetomidine, Liver Transplantation, Allograft Function, Survival in 330 participants. Completed in 31 December 2022.

Timeline

14 January 2019

Primary endpoint
31 October 2022

31 December 2022

Quick facts

Lead sponsor	RenJi Hospital
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	330
Start date	14 January 2019
Primary completion	31 October 2022
Estimated completion	31 December 2022
Sites	1 location across China

Drugs / interventions tested

• Dexmedetomidine (dexmedetomidine) — full drug profile →
• Saline

Conditions studied

• Dexmedetomidine, Liver Transplantation, Allograft Function, Survival — all drugs for Dexmedetomidine, Liver Transplantation, Allograft Function, Survival →

Sponsor

RenJi Hospital

Who can join

Adults 18 to 65, any sex, with Dexmedetomidine, Liver Transplantation, Allograft Function, Survival. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

1.1. Background 1.1.1. Perioperative ischaemia/reperfusion (I/R) injury during liver transplantation is strongly associated with early allograft dysfunction, graft loss, and mortality.

1.1.2. Hepatic I/R injury also causes remote damage to other organs including the renal and pulmonary systems.

1.1.3. Dexmedetomidine, a selective α2-adrenoceptor agonist which is widely used as an adjuvant to general anaesthesia, has been widely shown in preclinical studies to provide organoprotection by ameliorating the effects of I/R injury in a range of tissues (including the liver). However, prospective clinical evidence of any potential benefits in improving outcomes in liver transplantation is lacking.

1.2. Objectives 1.2.1. To investigate the hypothesis that perioperative treatment with dexmedetomidine reduces the incidence of early allograft dysfunction and primary graft non-function in deceased donor liver transplantation.

1.2.2. The impact of dexmedetomidine on postoperative renal and pulmonary function will also be examined.

1.3. Study Design This is a prospective, single-centre, randomised, parallel-group study.

1.4. Setting Departments of Anesthesiology, Renji Hosptial, Shanghai Jiao Tong University School of Medicine, Shanghai, 200127, China.

1.5. Patients 200 patients (18-65 years) scheduled to undergo liver transplantation under general anaesthesia.

1.6 Intervention 1.6.1. For the patients in the treatment group, a loading dose of dexmedetomidine will be given after induction of anaesthesia (1μg/kg over 10 min) followed by a continuous infusion (0.5μg/kg /h) until the end of surgery.

1.6.2. For patients in the placebo group, an equal volume loading dose of 0.9% saline will be given after the induction of anaesthesia followed by an equal volume continuous infusion until the end of surgery.

1.6.3. All other supplements, e.g. opioids, sedatives and muscle relaxant, will be identical in the both arms and administered according to routine clinical practice.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dexmedetomidine use during orthotopic liver transplantation surgery on early allograft dysfunction: a randomized controlled trial.
   Yang L, Zhu L, Qi B, Zhang Y, et al · · 2024 · cited 7× · PMID 38768468 · DOI 10.1097/js9.0000000000001669
2. Effect of intraoperative dexmedetomidine on hepatic ischemia-reperfusion injury in pediatric living-related liver transplantation: A propensity score matching analysis.
   Zhang L, Cui LL, Yang WH, Xue FS, et al · · 2022 · cited 7× · PMID 35965870 · DOI 10.3389/fsurg.2022.939223
3. Study design of the DAS-OLT trial: a randomized controlled trial to evaluate the impact of dexmedetomidine on early allograft dysfunction following liver transplantation.
   Ni C, Masters J, Zhu L, Yu W, et al · · 2020 · cited 5× · PMID 32591004 · DOI 10.1186/s13063-020-04497-7