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

Daniel Martin; Rahul Koti; Kurinchi Gurusamy; Louise Longworth; Jeshika Singh; Farid Froghi; Fiammetta Soggiu; Susan Mallett; Nick Schofield; Linda Selves; Douglas Thorburn; Christine Eastgate; Helder Filipe; Margaret McNeil; Zacharias Anastasiou; Brian Davidson; COLT study group

doi:10.1016/j.hpb.2019.11.011

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

HPB (Oxford). 2020 Aug;22(8):1112-1120. doi: 10.1016/j.hpb.2019.11.011. Epub 2019 Dec 23.

Authors

Daniel Martin¹, Rahul Koti², Kurinchi Gurusamy³, Louise Longworth⁴, Jeshika Singh⁵, Farid Froghi², Fiammetta Soggiu², Susan Mallett⁶, Nick Schofield⁶, Linda Selves⁷, Douglas Thorburn⁷, Christine Eastgate⁶, Helder Filipe⁶, Margaret McNeil⁶, Zacharias Anastasiou⁸, Brian Davidson⁹; COLT study group

Collaborators

COLT study group:
Lasitha Abeysundara, Zacharias Anastasiou, Janice Baker, Elaine Burrell, Judith C Leen, James Cuell, Brian Davidson, Christine Eastgate, Helder Filipe, Kate Flavin, Farid Froghi, Kate Fryer, Vignesh Gopalan, Kurinchi Gurusamy, Vivienne Hannon, Katherine, Horner, Sarah James, Rupinda Kaur, Rahul Koti, Louise Longworth, Daniel Martin, Kelly Martin, Susan Mallet, Margaret McNeil, Clare Morkane, Asya Mussad, Moira Perrin, Oliver Pietroni, Manuel Pinto, Jonathan Price, Katie Quist, Polin Rajaratnam, Sanjoy Saha, Nick Schofield, Linda Selves, Dee Sexton, Jeshika Singh, Fiametta Soggiu, Alexa Strachan, Sonali Thakrar, Douglas Thorburn

Affiliations

¹ University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK; Royal Free Perioperative Research Group, Department of Anaesthesia, Royal Free Hospital, 3rd Floor, Pond Street, London, NW3 2QG, UK.
² University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK; Hepato-Pancreato-Biliary and Liver Transplant Unit, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.
³ University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.
⁴ PHMR Limited, Berkeley Works, Berkley Grove, London, NW1 8XY, UK.
⁵ PHMR Limited, Berkeley Works, Berkley Grove, London, NW1 8XY, UK; Health Economics Research Group, Brunel University, Uxbridge, UB8 3PH, UK.
⁶ Royal Free Perioperative Research Group, Department of Anaesthesia, Royal Free Hospital, 3rd Floor, Pond Street, London, NW3 2QG, UK.
⁷ Hepato-Pancreato-Biliary and Liver Transplant Unit, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.
⁸ Department of Statistical Science, University College London, Gower St, London, WC1E 6BT, UK.
⁹ University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK; Hepato-Pancreato-Biliary and Liver Transplant Unit, Royal Free Hospital, Pond Street, London, NW3 2QG, UK. Electronic address: b.davidson@ucl.ac.uk.

PMID: 31874736
DOI: 10.1016/j.hpb.2019.11.011

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.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Cardiac Output
Feasibility Studies
Fluid Therapy
Humans
Liver Transplantation*
Prospective Studies
Quality of Life

Grants and funding

PB-PG-0214-33043/DH_/Department of Health/United Kingdom