OCOSO2: study protocol for a single-blinded, multicentre, randomised controlled trial assessing a central venous oxygen saturation-based goal-directed therapy to reduce postoperative complications in high-risk patients after elective major surgery.

Autor: Pastene B; Department of Anaesthesiology and Intensive Care Unit, Hôpital Nord, Hôpitaux Universitaires de Marseille, Marseille, France. bruno.pastene@ap-hm.fr.; Centre for Cardiovascular and Nutrition Research (C2VN), INRA, Aix Marseille University, INSERM, Marseille, France. bruno.pastene@ap-hm.fr., Bernat M; Department of Anaesthesiology and Intensive Care Unit, Hôpital Nord, Hôpitaux Universitaires de Marseille, Marseille, France., Baumstark K; Department of Epidemiology and Health Economy, Hôpitaux Universitaires de Marseille, Marseille, France., Bezulier K; Department of Anaesthesiology and Intensive Care Unit, Hôpital Nord, Hôpitaux Universitaires de Marseille, Marseille, France., Gricourt Y; Department of Anaesthesiology and Pain Management, Centre Hospitalo-Universitaire Carémeau, Nîmes and Montpellier University 1, Nîmes, France., De Guibert JM; Department of Anaesthesiology and Intensive Care Unit, Institut Paoli Calmettes, Marseille, France., Charvet A; Department of Anaesthesiology and Intensive Care Unit, Hôpital Nord, Hôpitaux Universitaires de Marseille, Marseille, France., Colin M; Department of Anaesthesiology and Intensive Care Unit, Hôpital Nord, Hôpitaux Universitaires de Marseille, Marseille, France., Leone M; Department of Anaesthesiology and Intensive Care Unit, Hôpital Nord, Hôpitaux Universitaires de Marseille, Marseille, France.; Centre for Cardiovascular and Nutrition Research (C2VN), INRA, Aix Marseille University, INSERM, Marseille, France., Zieleskiewicz L; Department of Anaesthesiology and Intensive Care Unit, Hôpital Nord, Hôpitaux Universitaires de Marseille, Marseille, France.; Centre for Cardiovascular and Nutrition Research (C2VN), INRA, Aix Marseille University, INSERM, Marseille, France.
Jazyk: angličtina
Zdroj: Trials [Trials] 2023 Oct 11; Vol. 24 (1), pp. 659. Date of Electronic Publication: 2023 Oct 11.
DOI: 10.1186/s13063-023-07689-z
Abstrakt: Background: Fluid loading-based goal-directed therapy is a cornerstone of anaesthesia management in major surgery. Its widespread application has contributed to a significant improvement in perioperative morbidity and mortality. In theory, only hypovolemic patients should receive fluid therapy. However, to achieve such a diagnosis, a surrogate marker of cardiac output adequacy must be used. Current methods of fluid loading-based goal-directed therapy do not assess cardiac output adequacy. Nowadays, new devices make it possible to continuously monitor central venous oxygen saturation (ScvO 2 ) and therefore, to assess the adequacy of perioperative cardiac output during surgery. In major surgery, ScvO 2 -based goal-directed therapy can be used to enhance fluid therapy and improve patient outcomes.
Methods: We designed a prospective, randomised, single-blinded, multicentre controlled superiority study with a 1:1 allocation ratio. Patients to be included will be high-risk major surgery patients (> 50 years old, ASA score > 2, major intra-abdominal or intra-thoracic surgery > 90 min). Patients in the control group will undergo standard fluid loading-based goal-directed therapy, as recommended by the guidelines. Patients in the intervention group will have ScvO 2 -based goal-directed therapy and receive fluid loading only if fluid responsiveness and cardiac output inadequacy are present. The primary outcome will be the Comprehensive Complication Index on day five postoperatively.
Discussion: This study is the first to address the issue of cardiac output adequacy in goal-directed therapy. Our hypothesis is that cardiac output optimisation during major surgery achieved by continuous monitoring of the ScvO 2 to guide fluid therapy will result in a reduction of postoperative complications as compared with current goal-directed fluid therapy practices.
Trial Registration: ClinicalTrials.gov. NCT03828565. Registered on February 4, 2019.
(© 2023. BioMed Central Ltd., part of Springer Nature.)
Databáze: MEDLINE
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