NCT02079402.

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Background The fluid balance associated with a better outcome following emergency surgery is unknown. The aim of this study was to explore the association of the perioperative fluid balance and postoperative complications during emergency gastrointestinal surgery. Methods We retrospectively included patients undergoing emergency surgery for gastrointestinal obstruction or perforation. A perioperative fluid balance of 2.5 L divided the cohort in a conservative and liberal group. Outcome was Clavien-Dindo graded complications registered 90 days postoperatively. We used logistic regression adjusted for age, sex, American Society of Anesthesiologists’ classification, use of epidural analgesia, use of vasopressor, type of surgery, intraabdominal pathology, and hospital. Predicted risk of complications was demonstrated on a continuous scale of the fluid balance. Results We included 342 patients operated between July 2014 and July 2015 from three centers. The perioperative fluid balance was 1.6 L IQR [1.0 to 2.0] in the conservative vs. 3.6 L IQR [3.0 to 5.3] in the liberal group. Odds ratio of overall 2.6 (95% CI 1.5 to 4.4), p < 0.001, and cardiopulmonary complications 3.2 (95% CI 1.9 to 5.7), p < 0.001, were increased in the liberal group. A perioperative fluid balance of 0–2 L was associated with minimal risk of cardiopulmonary complications compared to 1.5–3.5 L for renal complications. Conclusion We found a perioperative fluid balance above 2.5 L to be associated with an increased risk of overall and cardiopulmonary complications following emergency surgery for gastrointestinal obstruction or perforation. A perioperative fluid balance of 0–2 L was associated with the lowest risk of cardiopulmonary complications and 1.5–3.5 L for renal complications.

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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.