Your browser doesn't support javascript.
loading
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.
Edwards, Mark R; Forbes, Gordon; MacDonald, Neil; Berdunov, Vladislav; Mihaylova, Borislava; Dias, Priyanthi; Thomson, Ann; Grocott, Michael Pw; Mythen, Monty G; Gillies, Mike A; Sander, Michael; Phan, Tuong D; Evered, Lisbeth; Wijeysundera, Duminda N; McCluskey, Stuart A; Aldecoa, Cesar; Ripollés-Melchor, Javier; Hofer, Christoph K; Abukhudair, Hussein; Szczeklik, Wojciech; Grigoras, Ioana; Hajjar, Ludhmila A; Kahan, Brennan C; Pearse, Rupert M.
Afiliación
  • Edwards MR; Department of Anaesthesia, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
  • Forbes G; Acute, Critical & Perioperative Care Research Group, NIHR Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, UK.
  • MacDonald N; Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.
  • Berdunov V; Department of Perioperative and Pain Medicine, Royal London Hospital, Barts Health NHS Trust, London, UK.
  • Mihaylova B; Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.
  • Dias P; Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
  • Thomson A; Queen Mary University of London, London, UK.
  • Grocott MP; Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.
  • Mythen MG; Department of Anaesthesia, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
  • Gillies MA; Acute, Critical & Perioperative Care Research Group, NIHR Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, UK.
  • Sander M; University College London Hospitals NIHR Biomedical Research Centre, London, UK.
  • Phan TD; Department of Anaesthesia, Critical Care and Pain Medicine, Royal Infirmary of Edinburgh, Edinburgh, UK.
  • Evered L; Department of Anaesthesiology and Intensive Care Medicine, UKGM University Hospital Gießen, Justus-Liebig-University Giessen, Gießen, Germany.
  • Wijeysundera DN; St Vincent's Hospital Melbourne, and Anaesthesia, Perioperative and Pain Medicine Unit, University of Melbourne, Melbourne, Australia.
  • McCluskey SA; St Vincent's Hospital Melbourne, and Anaesthesia, Perioperative and Pain Medicine Unit, University of Melbourne, Melbourne, Australia.
  • Aldecoa C; Department of Anesthesia, Toronto General Hospital and University of Toronto, Toronto, Canada.
  • Ripollés-Melchor J; Department of Anesthesia, Toronto General Hospital and University of Toronto, Toronto, Canada.
  • Hofer CK; Hospital Universitario Rio Hortega, Valladolid, Spain.
  • Abukhudair H; Infanta Leonor University Hospital, Madrid, Spain.
  • Szczeklik W; Institute of Anaesthesiology and Intensive Care Medicine, Triemli City Hospital, Zurich, Switzerland.
  • Grigoras I; King Hussein Cancer Center, Amman, Jordan.
  • Hajjar LA; Department of Intensive Care and Perioperative Medicine, Jagiellonian University Medical College, Krakow, Poland.
  • Kahan BC; Regional Institute of Oncology Iasi, "Grigore T Popa" University of Medicine and Pharmacy Iasi, Iasi, Romania.
  • Pearse RM; Intensive Care Unit, Department of Cardiopneumology, University of Sao Paulo, São Paulo, Brazil.
BMJ Open ; 9(1): e023455, 2019 01 15.
Article en En | MEDLINE | ID: mdl-30647034
INTRODUCTION: Postoperative morbidity and mortality in older patients with comorbidities undergoing gastrointestinal surgery are a major burden on healthcare systems. Infections after surgery are common in such patients, prolonging hospitalisation and reducing postoperative short-term and long-term survival. Optimal management of perioperative intravenous fluids and inotropic drugs may reduce infection rates and improve outcomes from surgery. Previous small trials of cardiac-output-guided haemodynamic therapy algorithms suggested a modest reduction in postoperative morbidity. A large definitive trial is needed to confirm or refute this and inform widespread clinical practice. METHODS: The Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial is a multicentre, international, parallel group, open, randomised controlled trial. 2502 high-risk patients undergoing major elective gastrointestinal surgery will be randomly allocated in a 1:1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intravenous fluid combined with low-dose inotrope infusion, or usual care. The trial intervention will be carried out during and for 4 hours after surgery. The primary outcome is postoperative infection of Clavien-Dindo grade II or higher within 30 days of randomisation. Participants and those delivering the intervention will not be blinded to treatment allocation; however, outcome assessors will be blinded when feasible. Participant recruitment started in January 2017 and is scheduled to last 3 years, within 50 hospitals worldwide. ETHICS/DISSEMINATION: The OPTIMISE II trial has been approved by the UK National Research Ethics Service and has been approved by responsible ethics committees in all participating countries. The findings will be disseminated through publication in a widely accessible peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER: ISRCTN39653756.
Asunto(s)
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Complicaciones Posoperatorias / Procedimientos Quirúrgicos del Sistema Digestivo / Cardiotónicos Tipo de estudio: Clinical_trials / Guideline / Risk_factors_studies Aspecto: Ethics Límite: Aged / Female / Humans / Male Idioma: En Revista: BMJ Open Año: 2019 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Complicaciones Posoperatorias / Procedimientos Quirúrgicos del Sistema Digestivo / Cardiotónicos Tipo de estudio: Clinical_trials / Guideline / Risk_factors_studies Aspecto: Ethics Límite: Aged / Female / Humans / Male Idioma: En Revista: BMJ Open Año: 2019 Tipo del documento: Article Pais de publicación: Reino Unido