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

Abstract

IntroductionIntravenous 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/analysisThis 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 disseminationThe 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 numberEudraCT 2015-000563-14.

The association of the perioperative fluid balance and cardiopulmonary complications in emergency gastrointestinal surgery: exploration of a randomized trial

“…2015-000563-14). The rationale and design of the GAS-ART trial were published before study completion (Voldby et al 2018).…”

“…The secondary outcomes were renal, woundrelated, or infectious complications. These outcomes represent our hypotheses for the original trial that the fluid balance influenced cardiopulmonary, wound healing, renal, and infectious complications (Voldby et al 2018).…”

“…The diagnostic criteria of the individual complications are given in the original trial (Voldby et al 2018;Aaen et al 2021).…”

“…All enrolled patients provided informed oral and written consent. The rational and design of the GAS-ART trial was published before study completion (Voldby et al 2018).…”