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Goal-directed fluid therapy in urgent GAstrointestinal Surgery-study protocol for A Randomised multicentre Trial: The GAS-ART trial

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INTRODUCTION: Intravenous fluid therapy during gastrointestinal surgery is a life-saving part of the perioperative care. Too little fluid may lead to hypovolaemia, decreased organ perfusion and circulatory shock. Excessive fluid administration increases postoperative complications, worsens pulmonary and cardiac function as well as the healing of surgical wounds. Intraoperative individualised goal-directed fluid therapy (GDT) and zero-balance therapy (weight adjusted) has shown to reduce postoperative complications in elective surgery, but studies in urgent gastrointestinal surgery are sparse. The aim of the trial is to test whether zero-balance GDT reduces postoperative mortality and major complications following urgent surgery for obstructive bowel disease or perforation of the gastrointestinal tract compared with a protocolled standard of care.

METHODS/ANALYSIS: This study is a multicentre, randomised controlled trial with planned inclusion of 310 patients. The randomisation procedure is stratified by hospital and by obstructive bowel disease and perforation of the gastrointestinal tract. Patients are allocated into either 'the standard group' or 'the zero-balance GDT group'. The latter receive intraoperative GDT (guided by a stroke volume algorithm) and postoperative zero-balance fluid therapy based on body weight and fluid charts. The protocolled treatment continues until free oral intake or the seventh postoperative day.The primary composite outcome is death, unplanned reoperations, life-threatening thromboembolic and bleeding complications, a need for mechanical ventilation or dialysis. Secondary outcomes are additional complications, length of hospital stay, length of stay in the intensive care unit, length of mechanical ventilation, readmissions and time to death. Follow-up is 90 days.We plan intention-to-treat analysis of the primary outcome.

ETHICS AND DISSEMINATION: The Danish Scientific Ethics Committee approved the GAS-ART trial before patient enrolment (J: SJ-436). Enrolment of patients began in August 2015 and is proceeding. We expect to publish the GAS-ART results in Summer 2019.

TRIAL REGISTRATION NUMBER: EudraCT 2015-000563-14.

OriginalsprogEngelsk
TidsskriftBMJ Open
Vol/bind8
Udgave nummer11
Sider (fra-til)e022651
ISSN2044-6055
DOI
StatusUdgivet - 13 nov. 2018

ID: 56704556