The cardiac output optimisation following liver transplant (COLT) trial: a feasibility randomised controlled trial

Abstract

Background: Perioperative goal directed fluid therapy (GDFT) has been shown to reduce postoperative complications following major surgery; this intervention has not been formally evaluated in the setting of liver transplantation. Methods:We conducted a prospective trial of GDFT following liver transplantation randomising patients with liver cirrhosis to either 12 h of GDFT using non-invasive cardiac output monitoring or standard care (SC). The primary outcome was feasibility. Secondary outcomes included survival, postoperative complications (Clavien-Dindo), quality of life (by EQ-5D-5L) and resource use. Trial specific follow up occurred at 90 and 180 days after surgery. Results:The study was feasible. Of 224 eligible patients, 122 were approached, 114 consented to participate and 60 were enrolled into the trial. The mean (SD) volume of IV crystalloid administered to the GDFT group during the 12-h study period was 3968 (2073) ml for the GDFT group and 2510 (1026) ml for the SC group. As regards secondary outcomes there was no difference in survival or overall complication rates. There was no significant difference in quality of life scores and resource use between the groups. Conclusion:A randomised study of GDFT following liver transplantation is feasible. A post-trial stakeholder meeting supported proceeding with a full multi-centre trial.

Perioperative fluid management and outcomes in adult deceased donor liver transplantation – A systematic review of the literature and expert panel recommendations

“…There is also very limited evidence on both intraoperative and postoperative goal-directed fluid therapy, a technique showing a variable effect on fluid balance depending on protocol details. 7,8 Likewise, population-specific data to inform recommendations on type of crystalloid or colloid-containing fluid used as an adjunct to red cell and plasma replacement are not yet available, except that, based on low-quality evidence, administration of 130/.4 HES may be inadvisable given the high risk of AKI in this setting (Table 6). Expert opinion also suggests that the sodium content of resuscitation fluids should be considered in recipients with moderate-to-severe hyponatremia, in whom rapid increases in plasma sodium may cause neurological injury.…”

The Effects of sodium bicarbonate Ringer’s solution on acute kidney injury and the clinical outcomes after liver transplantation: A randomized controlled trial

“…From the beginning of anesthetic induction, the participants were treated with 2 ml/kg/h crystalloid solutions. Goal-directed hemodynamic management was used to guide the intravenous crystalloid infusion ( Martin et al, 2020 ; Froghi et al, 2022 ). When there was no bleeding, 2 ml/kg/h was the background infusion volume.…”

Understanding recruitment to a perioperative randomised controlled trial: protocol for a mixed-methods substudy nested within a feasibility trial of octreotide infusion during liver transplantation

“…The mixed-methods fieldwork will only be undertaken if the observed recruitment:approach ratio is below predetermined thresholds of <0.3 at the RFH, or <0.15 at University Hospitals Birmingham (UHB), after at least 12 patients at each site, or if the RCT team have specific concerns about recruitment processes. The predetermined thresholds have been chosen to reflect recruitment rates during a previous RCT in this patient population at the RFH, 10 and lower recruitment rates at secondary centres.…”

“…As there can be a prolonged time period on the transplant waiting list, consent will be confirmed (‘enrolment’) on admission to hospital for their transplant (online supplemental appendix 1). This strategy has been successfully implemented in comparable interventional studies in this population 10. The focus of our study will be the initial recruitment stage.…”

“…This strategy has been successfully implemented in comparable interventional studies in this population. 10 The focus of our study will be the initial recruitment stage.…”