Fluid Optimisation in Emergency Laparotomy (FLO-ELA) Trial: study protocol for a multi-centre randomised trial of cardiac output-guided fluid therapy compared to usual care in patients undergoing major emergency gastrointestinal surgery
Authors: Edwards Mark R. , Forbes Gordon , Walker Neil , Morton Dion G. , Mythen Monty G. , Murray Dave , Anderson Iain , Mihaylova Borislava , Thomson Ann , Taylor Matt , Hollyman Marianne , Phillips Rachel , Young Keith , Kahan Brennan C. , Pearse Rupert M. , Grocott Michael P. W. ,   for the FLO-ELA investigators, Skubala Alexandra , Tapley Patrick , Kellett Suzanne , Bolger Clare , Burnish Rachel , Collings Nikki , Cumpstey Andrew , Wong Hannah , Rehnberg Vic , Lees Jessica , Salmon Karen , Wee Naomi , Harrison Sarah , Gan Li Ping , Halloran Claire , Tsiopanis Georgios , Seifalian Said , Webster Richard , Knight Martin , Theobald Hannah , Clark Anna , Nicholls Thomas , Willey James , Beeby Sophia , Bracegirdle Luke , Stoddard Kate , Roberts Belinda , Baker Alice , Diaper Norma , Biss Jonathan , Carter Michael , Riccio Francesca , Green James , Johnstone Lucy , Rand Jade , Wisniewska Kasia , Gibson Grant , Bateson Hannah , Beveridge Michelle , Marani Martyna , Monger Isabel , Burtt Agnieszka , Minto Gary , Christie Iain , Fergusson Anna , Patrick Abigail , Cleland Stuart , Eglinton Charlotte , Wilmshurst Natasha , Reed Fiona , Smith Joanne , Ratcliffe Anna , Freeman Elizabeth , Kingdon Jennie , Humphreys James , Nelson Sarah , Jennings Adrian , Watts Angela , Moores Andrew , Smith Lucy , Wright Jenny , Sonksen Julian , Moody Caroline , Harrington Philip , Lee Jack , Kozman Nadim , Riddell Zoe , Brennan Catherine , Nathoo Shakira , Anumakonda Vikram , Gait Andrea , Pierson Richard , Patel Raj , Plant Lee , Agarwal Nipun , Ihlenfeldt Hadassah , Heggie James , Olive Rachel , Pick Joseph , Hinsley Sally , Calthorpe Nicola , Matthews Julie , Gardner Wendy , Topham Charlotte , Jones Edward , Yates Elliot , Sekhsaria Sachin , Amer Mohamed , Pemberton Phil , Coffin Nicholas , Hutchinson-Bazely Halden , Pearson Karen June , Edwards Tracy , Fitzmaurice Beth , Pierson Anna , Archer Katie , Ahmed Omar , Mohammed Sajid Khan , Hollis Alex , Weedon Stephanie , Hillier David , Lau Joanna , Amin Vishal , Dixon Laura , Seager Joseph , Tyler Joe , Forsey Stacey , Parry N. , Mughal Aamer , Goh Jialuen , Tiller Rose , Taylor Daniel , Rallage Hasini , Leech Alexandra , Harris John , Gabriel Claire , Clarke Sheron , Pagett Katherine , Rudnick Thomas , Brown Nick , Hare Sarah , Lusby Eimhear , Bayliss Edward , Ward Christopher , Bandopadhyay Rahul , Wilson Kerrie , Floyd Theodore , Ahmed Iram , Hatton Tom , Szeszo Malgorzata , Kyere-Diabour Thyra , Sumner Daniel , Lawrence Tessa , Sutton Emma , Ng Winston , Kapsokalyuas Ioannis , Carter Anthony , Kansal Anamika , Bernard Leon , Harrison Siew-Ling , Feneley Andrew , Cooke Owen , Hawley Jennifer , Berry Sophie , Adams Laura , Hansen Thomas , Bothma Pieter , North Julie , Ferreira Teresa , Verma Karan , Surendran Karthik , Arumugam Aruthy , Jamadarkhana Sunil , Cruz Carina , Baker Pearl , Brice Naomi , Ashton Antony , Mupudzi McDonald , Kemp Juliette , Rahl Ajay , Griffin Denise , Stokes Aaron , Ritchie Keith , Venkatasubramaniam Arcot , Cheek Robert , Brown Madonna , Trodd Dawn , Brown Caroline Wrey , Martin Jane , Hammond Sam , Mason Louisa , Muchenje Nycola , Breach Hamish , Colston Amanda , Watters Malcolm , Miles Edwards , Marshall Emma , Storey Madeleine , Hawley Victoria , Gomm Edward , Potter Claire , Knowles Melanie , Beech Edward , van Breda Peter , Langton Helen , Suarez Nicholas , Rowe Matthew , Tanase Andrei , Barnes Jonathan , Earl David , Stephenson Lorraine , Burdett Tracy , Huntley Martin , Cottrell Emma , Tan Hao Ern , Yeung Joyce , Kailey Jasraj , Melody Teresa , Gresty Jo , Sampson Julia , Atterbury Katie , Sutton Peter , Carling Natalie , Reeves Eleanor , Groves Carl , Crossmann Daniel , Ballinger Sarah , Smith Rachel , Thomas Marie , Rook Will , Mooradun Mohamed , Khan Qasim , Qureshi Arif , Fenton-May Llewellyn , Boulton Adam , Whitney Daniel , Sannakki Shilpa , Avinash Manekar , Lee Nikiesha , Sharma Neha , Magham Srinivas , Moncaster Gareth , Boulton Rebecca , Sewell Terri-Ann , Lovegrove Wayne , Tansley John , Watson Nick , Shelton Sarah , Heeley Cheryl , Buckley Philip , Slack Katie , Holmes Rebecca , Palfreman Andrea , Smith Christopher , Gill Mandy , Smith Sue , Brear Tracy , Kirk Jill , Holmes Megan , Goodwin Camelia , Flynn Margaret , Wynter Inez , Bennett Kaytie , Harris Stephen , Pawley Corrine , Doble Patricia , Tait Moira , Gibbs Richard , Edwards Tom , Mackey Paul , Hunt Miss Louise , Hutter Jo , Smyth Ed , Noble Hamish , Judd Thomas , Arkell Rose , Thomas Owen , Watura Karen , Vaida Marius , Rahman Suehana , Sufi Saaidullah , Filipe Helder , Eastgate Christine , McNeil Margaret , Howey Stephen , Pakou Glykeria , Mingo Sara , Maharajh Amitaa , Grecu Irina , Hammond Samantha , Hanson Susan , Ottaway Julia , Burgess Victoria , Fry James , Watson Geoff , Wessels Francois , Cutler Hugh , Goldsmith Arthur , Howes Mark , Sivasubramaniam Subash , Colley Julie , Porter Jenny , Krishnan K. P. , Aldridge Kerrie , Willetts Sylvia , Zullo Carol , Thompson Christopher , Shanmugasundaram Pradeep , Abrams Judith , Manso Katarina , Razzaque Jamil , Scott Sally , Hambrook Geraldine , McKerrow Elizabeth , Ali Tahir , Ankers Alastair , Ranganathan Mohan , Bellam Sunil , Mason Sophie , Marriott Paul , Robley Richard , Campbell Bridget , Parsons Penny , Ramcharan Sean , Mohamed Anver Susanne , Page Valerie , Walker Elaine , Zhao Xiaobei , Osborne Laura , Parker Beena , Kaur Rupinder , Kulakauskaite-Rasteniene Gitana , Patel Mehul , Lowe Alastair , Edmunds Emma , Hills Kieran , Klimovskij Michail , Ranns Christopher , Ganesh Radha , Jones David , Gibson Jamie , Sinclair Janet , Burton Karen , De Freitas Toni , Dryden Leon , Robinson Amelia , Udezue Nnamdi , Faccini Tim , Majumdar Moon-Moon , Death Kelly , Baba Hide , Narendran Jaydraman , Claxton Bret , Brennan Andrew , Akeroyd Louise , Cooper Sarah , Farrow Catherine , Ilyas Carl , Morgan James , Montgomery Craig , Wilkinson Brian , 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Gooneratne Mevan , Sharma Chhaya , MacDonald Neil , Whalley Jan , Dias Priyanthi , Ackland Gareth , Shirley Peter , Stephens Tim , Zolfaghari Parjam , Dunkley Steven , Reynolds Toby , Walton Henry , Smith Matthew , Bali Shreya , Hui Sara , Bhatia Ravi , Torrance Hew , Fernandez Maria , Uddin Ruzena , Santos Filipa , Arrieta Amaia , Barrett Stephen , Cashmore Richard , Richards Eleanor , Seidu Fatima , McIlroy Edward , Urwin Thomas , Samuel John , Brooks Katherine , Gravell Natalie , Blackwood Douglas , Sanghera Tanj , Joseph Mareena , Jalaly Aisha , Nugent Hannah , Goodman Ben , Scott Ashley , Clement Ian , Dunn Leigh , Harrison Abigail , Hays Carole , Babio-Galan Maite , Todd Sarah , Dawson Lindsay , Henderson Stephanie , Arora Kapil , Diwaker Subramani , Marcangelo Sam , Harvey James , Dalton Mark , Hyams Jeremy , Shrestha Tara , Zwiggelaar Kimberley , Heggie Laura , Sinclair Rhona , Brown Ben , Cope Sean , Traill Steven , Durrand James , Sheriff Julie , Allan Ashley , Woods Lindsey , Chuter Erin , Betts Rebecca , Thistlethwaite Rossalyn , Turnbull Elizabeth , Paul Monojit , Campbell Pete , Bashlijski Vlad , Foley Charlotte , Ginn Amy , Cookson Adam , Cornell Sarah , Pearson Janaki , Rogerson Kimberley , Eden-Green Ben , Mostert Marthin , Leong Maria , Kirkin Daniel James , Reece-Anthony Rosie , Ali Fatima , Heller Michaela , Mathew George , Madhavan Beenu , Powell Katherine , Dasey Noelene , Khaliq Waqas , Gurung Babita , Alkhadra Cristina , Mostafa Tarek , Winchester James , Thomas Megan , Soodan Amit , Nilo Alfa Cresia , Bridge Matthew , Jones-Criddle Colette , Wilding Laura , Turner-Bone Ian , Morton Ben , Gilbert Tim , Littley Nathan , Clarke Natasha , Moore Greg , Miller Tamryn , Rudnick Tom , Miller Tom , Haldar Manab , Nair Ashok , Jarvis Michael , Basvi Precious , Bell Gillian , Edwards Michelle , Mewies Clare , Vakis Stelios , Burton Emily , Yelamati Kiran , Das Amit , Bhattacharya Abhimanyu , Massey Daniel , Kalaiyarasan Ramkumar , Katary Amro , Maung 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Shahnavaz Jasmin , Bailey Duncan , Chicano Rosavic , Vilimiene Neringa , Ahmad Shahzaib , Richardson Neil , Mahmoud Youssef , McDonald Shanni , Schumacher Natasha , Velinova-Teron Svetlana , Silhi Rohit , Chivers Guy , Davies Julie-Ann , Cosier Tracey , Featherstone Barry , Rand James , Cook Esther , Neely Diana , Coombes John , Sodhi Harpreet , Burr Thomas , Oliver Mark , Walters Michelle , Jemmett Kim , Dulea Claudia , Cooper Lucy , Mcferran Sam , Rigaudy Maxime , Jennett Kim , Weston Heather , Solly Reanne , Ignall Emma , Praman Cathy , Hamlyn Vincent , Chinnappa-Srinivas Gayathri , Organ Angie , Moisin Tudor Vlad , Parnell Julia , Whitehead Matthew , Hayward Olivia , Malkin Rosie , Bennetton Zoe , Devine Anne , Green Tim , Hubert Joanna , Andrews Sam , Ward Deborah , Brown Pauline , Vallotton Nick , Glass Jon , O’Connell Susan , Bevan Alice , Brougham Tom , Kidd Lawrie , Hughes Sian , Stone Jeannine , Mann Deborah , Murray Helen , Davis Fiona , Eveleigh Mark , Hartford-Beynon Jake , Stratton Katherine , Ng Kat Yan Yee , Phull Mandeep , Joseph George , Gorrela Kalyani , Weerasekera Viraj , Sudhan Nazneen , Khan Ayub , Chalmers Louis , Huntley Ben , Chipperfield Sandra , George Aparna , Rosario Lace Paulyn , Pogreban Tatiana , Buhain Robert , Hussain Alia , Costa Asya Veluso , Richards Eleanor , Gibson Charles , Kusre Sandeep , Hutchings Melanie , Kelly Sinéad , Pugsley Rebecca , Malik Hamza , Beaney Alec , Woodward Tom , Essackjee Zahra , Chen Kangni , McCormick Bruce , Matthews Cath , Walter Michelle , Gordon Elizabeth , Heddon Sadie , Warrener Timothy , Valentine Peter , Prescott Joel , Keenan Samantha , Johnson Emily , Higgs Eleanor , Thrush Jessica , Tulloch Laura , Osborne Fiona , Poyntz Victoria , Takhar Pooja , Rowlands Connie , Mcalindon Michael , Lacey Victoria , Cowley Nicholas , Chamberlain Stephanie , Rudge Sally , Bhardwaj Sian , Freeman David , Spooner Brendan , Dalay Satinder , Fitton Nick , Davies Rebecca , Fisher Kay , Naumann Laura , Wong Elma , Leach Simon , Moore Helen , Wilcox Rebecca , Parry Rhys , Magness Alison , Carnahan Mandy , Travis Matthew , Adams Colene , Passey Samuel , Colebrook Richard , Elcock David , Mhembere Priscilla , Rankin Jayne , Cheng Yee Yin , Clulow Chris , Stickley Jo , Carter Anne , Stephens Alison , Buckingham Elizabeth , Price Laura , Jones Ryan , Taylor Andy , Ochoa-Ferraro Maria , Beard Harriette , Corfe Jeremy , Keshet-Price Jocelyn , Fottrell-Gould Deidre , Foot Gill , Hudig Lisa , Convery Karen , Oliver Martyn , Neil Hannah , Randell Georgina , Maxwell Melanie , Kuntumalla Kavitha , Gajendragadkar Pushpaj , Wu James , Huckle Danielle , Petley Stephen , Jones Nadine , Rahilly Karen , Williams Gail , Coakley Margaret , Jones Laura , Manetta-Jones Dominic , Churchill Sara , Fulton Laura , Jigajinni Suyogi , Collins Emma , Santos Fillipa , John Noah , Das Abhilash , Manville Christopher , Abbott Tom , Carter Hester , Kanapeckaite Lina , Stead Gavin , Holmes Jonathan , Ireson Amy , Gill Edward , Kwok Stephanie , Duncan Alastair , Greenlee Hannah , Venables Ian , Jama Rose , Moppett Iain , Peters Cecilia , Ryan Lucy , Conner Louise , Meredith Megan , Clark Amy , Noah Abi , Potter Louise , Lindsay Will , Parmar Jaina , Harvey Dan , Evans David , Chikhani Marc , Lowe Ben , O’Donoghue Kevin , Chana Avninder , Roke Rachel , Tsagurnis Ioannis , Dymond Harvey , Sleep David , Owens Kristina , Beer Rachel , Simmons Dawn , Cotterill Donna , Eka Ime , Beech Sandra , Ong Pei Jean , Ritchie David , Wilkinson Susan , Butler Matthew , Crossley David , Van Der Schyff Victoria , Ghazanfar Irum , Mawer Andrew , Almeida Ana , Duggal Lucy , Lightfoot Jonathan , Simpson Anna , O’Connell Susan , Rennison Tom , Thompson Robert , Fowler Susan , Pirie Sandra , Cochrane Patricia , Nesvadba David , Forget Patrice , Ganley Pauline , Noble Jennifer , Coutts Amanda , Jackson Sue , Prescott Tim , Smith William , Harrison Anne , Omuwie Emily , Johnson Rachel , Evans Jennifer , Rudd Rebecca , Loeffler Isobel , Veiga Catarina , Teoh Poh Choo , Chambers Samuel , Bumbac Oleg , Holcombe-Law Ross , Page Alexandria , Jackson Paul , George Daniel , Wilkinson Tess , Kirkin Daniel , Lloyd Michaela , Smith Leanne , Reddy Amie , McCaig William , Murrant Harriet , Masoud Ammara , Davis Mia , Pradhan Debasis , Rudkin Joanne , Byrne Matthew , Tsinaslaniois Georgios , Bafitis Vasileios , Black Christopher , George Cassandra , Keltos Marketa , Letts Maria , Allinson Victoria , Foulds Angela , Gittus Sophie , Aneesh Lakshmi , Nash Ayman , Kumar Prathiban , Graham James , Donnaly Andrew , Grigg Martin , Singh Ariana , Chawla Aastha , McGrady Calum , Walker Nicola , Brennan Christopher 
Published: May 2023

Abstract
Introduction
Postoperative morbidity and mortality in patients undergoing major emergency gastrointestinal surgery are a major burden on healthcare systems. Optimal management of perioperative intravenous fluids may reduce mortality rates and improve outcomes from surgery. Previous small trials of cardiac-output guided haemodynamic therapy algorithms in patients undergoing gastrointestinal surgery have suggested this intervention results in reduced complications and a modest reduction in mortality. However, this existing evidence is based mainly on elective (planned) surgery, with little evaluation in the emergency setting. There are fundamental clinical and pathophysiological differences between the planned and emergency surgical setting which may influence the effects of this intervention. A large definitive trial in emergency surgery is needed to confirm or refute the potential benefits observed in elective surgery and to inform widespread clinical practice.

Methods
The FLO-ELA trial is a multi-centre, parallel-group, open, randomised controlled trial. 3138 patients aged 50 and over undergoing major emergency gastrointestinal surgery will be randomly allocated in a 1:1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intra-venous fluid, or usual care without cardiac output monitoring. The trial intervention will be carried out during surgery and for up to 6 h postoperatively. The trial is funded through an efficient design call by the National Institute for Health and Care Research Health Technology Assessment (NIHR HTA) programme and uses existing routinely collected datasets for the majority of data collection. The primary outcome is the number of days alive and out of hospital within 90 days of randomisation. Participants and those delivering the intervention will not be blinded to treatment allocation. Participant recruitment started in September 2017 with a 1-year internal pilot phase and is ongoing at the time of publication.

Discussion
This will be the largest contemporary randomised trial examining the effectiveness of perioperative cardiac output-guided haemodynamic therapy in patients undergoing major emergency gastrointestinal surgery. The multi-centre design and broad inclusion criteria support the external validity of the trial. Although the clinical teams delivering the trial interventions will not be blinded, significant trial outcome measures are objective and not subject to detection bias.

Trial registration
ISRCTN 14729158. Registered on 02 May 2017.