Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial: Study protocol for a multicentre international trial of cardiac output-guided fluid therapy with low-dose inotrope infusion compared with usual care in patients undergoing major elective gastrointestinal surgery

BMJ Open

Volumn 9, Issue 1, 2019, Pages

  Edwards, Mark R ^a   Forbes, Gordon ^b   MacDonald, Neil ^c   Berdunov, Vladislav ^b   Mihaylova, Borislava ^b   Dias, Priyanthi ^b   Thomson, Ann ^b   Grocott, Michael P W ^a   Mythen, Monty G ^d   Gillies, Mike A ^e   Sander, Michael ^f   Phan, Tuong D ^g   Evered, Lisbeth ^g   Wijeysundera, Duminda N ^h   McCluskey, Stuart A ^h   Aldecoa, Cesar ⁱ   Ripollés Melchor, Javier ^j   Hofer, Christoph K ^k   Abukhudair, Hussein ^l   Szczeklik, Wojciech ^m   Grigoras, Ioana ⁿ   Hajjar, Ludhmila A ^o   Kahan, Brennan C ^b   Pearse, Rupert M ^b   more..

^a UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST   (United Kingdom)

^b QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^c ROYAL LONDON HOSPITAL   (United Kingdom)

^d UNIVERSITY COLLEGE LONDON HOSPITALS   (United Kingdom)

^e ROYAL INFIRMARY OF EDINBURGH   (United Kingdom)

^f UNIVERSITY HOSPITAL GIESSEN   (Germany)

^g UNIVERSITY OF MELBOURNE   (Australia)

^h UNIVERSITY OF TORONTO   (Canada)

ⁱ HOSPITAL UNIVERSITARIO RÍO HORTEGA   (Spain)

^j HOSPITAL UNIVERSITARIO INFANTA LEONOR   (Spain)

^k TRIEMLI HOSPITAL   (Switzerland)

^l KING HUSSEIN CANCER CENTER   (Jordan)

^m JAGIELLONIAN UNIVERSITY MEDICAL COLLEGE   (Poland)

ⁿ GRIGORE T POPA UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^o UNIVERSITY OF SÃO PAULO   (Brazil)

more..

Author keywords

elective surgical procedures adverse effects; hemodynamics physiology; intraoperative methods; prospective studies

Indexed keywords

INFUSION FLUID; INOTROPIC AGENT; CARDIOTONIC AGENT;

AGED; ARTICLE; CLINICAL PRACTICE; CONTROLLED STUDY; ELECTIVE SURGERY; FEMALE; FLUID THERAPY; GASTROINTESTINAL SURGERY; HEART OUTPUT; HIGH RISK PATIENT; HUMAN; INTERMETHOD COMPARISON; LONG TERM SURVIVAL; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MAJOR SURGERY; MALE; MEDICAL ETHICS; MINIMALLY INVASIVE SURGERY; MULTICENTER STUDY; OUTCOME ASSESSMENT; PERIOPERATIVE PERIOD; POSTOPERATIVE INFECTION; RANDOMIZED CONTROLLED TRIAL; RESEARCH ETHICS; ABDOMINAL SURGERY; INTRAVENOUS DRUG ADMINISTRATION; MULTICENTER STUDY (TOPIC); POSTOPERATIVE COMPLICATION; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC);

AGED; CARDIOTONIC AGENTS; DIGESTIVE SYSTEM SURGICAL PROCEDURES; FEMALE; FLUID THERAPY; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MULTICENTER STUDIES AS TOPIC; POSTOPERATIVE COMPLICATIONS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 85059505876     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2018-023455     Document Type: Article

References (31)

1. Weiser TG, Haynes AB, Molina G, et al. Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes. Lancet 2015;385:S11.
2. Abbott TEF, Fowler AJ, Dobbs TD, et al. Frequency of surgical treatment and related hospital procedures in the UK: a national ecological study using hospital episode statistics. Br J Anaesth 2017;119:249-57.
3. Pearse RM, Moreno RP, Bauer P, et al. Mortality after surgery in Europe: a 7 day cohort study. Lancet 2012;380:1059-65.
4. Findlay G, Goodwin A, Protopapa K, et al. Knowing the Risk. A review of the peri-operative care of surgical patients. London: NCEPOD, 2011.
5. The International Surgical Outcomes study group. Global patient outcomes after elective surgery: prospective cohort study in 27 low-, middle- and high-income countries. Br J Anaesth 2016;117:601-9.
6. Khuri SF, Henderson WG, De Palma RG, et al. Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg 2005;242:32-48.
7. Kahan BC, Koulenti D, Arvaniti K, et al. Critical care admission following elective surgery was not associated with survival benefit: prospective analysis of data from 27 countries. Intensive Care Med 2017;43:971-9.
8. NHS Digital. Hospital Episode Statistics, Admitted Patient Care, England - 2016-17. 2017 https:// digital. nhs. uk/ catalogue/ PUB30098.
9. Pearse RM, Harrison DA, MacDonald N, et al. Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA 2014;311:2181-90.
10. Bangash MN, Patel NS, Benetti E, et al. Dopexamine can attenuate the inflammatory response and protect against organ injury in the absence of significant effects on hemodynamics or regional microvascular flow. Crit Care 2013;17:R57.
11. Jhanji S, Vivian-Smith A, Lucena-Amaro S, et al. Haemodynamic optimisation improves tissue microvascular flow and oxygenation after major surgery: a randomised controlled trial. Crit Care 2010;14:R151.
12. Pearse R, Dawson D, Fawcett J, et al. Changes in central venous saturation after major surgery, and association with outcome. Crit Care 2005;9:R694.
13. Grocott MP, Dushianthan A, Hamilton MA, et al. Perioperative increase in global blood flow to explicit defined goals and outcomes following surgery. Cochrane Database Syst Rev 2012;11:CD004082.
14. Sadique Z, Harrison DA, Grieve R, et al. Cost-effectiveness of a cardiac output-guided haemodynamic therapy algorithm in high-risk patients undergoing major gastrointestinal surgery. Perioper Med 2015;4:13.
15. Gillies MA, Shah AS, Mullenheim J, et al. Perioperative myocardial injury in patients receiving cardiac output-guided haemodynamic therapy: a substudy of the OPTIMISE Trial. Br J Anaesth 2015;115:227-33.
16. Brienza N, Giglio MT, Marucci M, et al. Does perioperative hemodynamic optimization protect renal function in surgical patients? A meta-analytic study. Crit Care Med 2009;37:2079-90.
17. Ahmad T, Beilstein CM, Aldecoa C, et al. Variation in haemodynamic monitoring for major surgery in European nations: secondary analysis of the EuSOS dataset. Perioper Med 2015;4.
18. Thomas C, Allen C. Impact of NICE guidance and CQUINS on uptake of cardiac output monitors across the NHS: a trainee-led national survey. Br J Anaesth 2015;115:e950-62.
19. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200-7.
20. Deans KJ, Minneci PC, Danner RL, et al. Practice misalignments in randomized controlled trials: Identification, impact, and potential solutions. Anesth Analg 2010;111:444-50.
21. MacDonald N, Ahmad T, Mohr O, et al. Dynamic preload markers to predict fluid responsiveness during and after major gastrointestinal surgery: an observational substudy of the OPTIMISE trial. Br J Anaesth 2015;114:598-604.
22. Kahan BC, Rehal S, Cro S. Risk of selection bias in randomised trials. Trials 2015;16:405.
23. White IR, Horton NJ, Carpenter J, et al. Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ 2011;342:d40.
24. Kahan BC. Accounting for centre-effects in multicentre trials with a binary outcome - when, why, and how? BMC Med Res Methodol 2014;14:20.
25. Kahan BC, Rushton H, Morris TP, et al. A comparison of methods to adjust for continuous covariates in the analysis of randomised trials. BMC Med Res Methodol 2016;16:42.
26. Harrell FE. Regression Modeling Strategies. New York, NY: Springer New York, 2001. http://link.springer.com/. (accessed 21 Jul 2016).
27. White IR, Thompson SG. Adjusting for partially missing baseline measurements in randomized trials. Stat Med 2005;24:993-1007.
28. Digital NHS. Hospital Episode Statistics. 2018 http:// content. digital. nhs. uk/ hes (accessed 10 Oct 2016).
29. Department of Health. NHS Reference Costs 2016-2017, 2018. https:// improvement. nhs. uk/ resources/ reference- costs/. (accessed 2 Mar 2018).
30. Dolan P. Modeling valuations for EuroQol health states. Med Care 1997;35:1095-108.
31. Briggs AH, Gray AM. Handling uncertainty when performing economic evaluation of healthcare interventions. Health Technol Assess 1999;3:1-134.