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Goal-directed fluid therapy in urgent GAstrointestinal Surgery—study protocol for A Randomised multicentre Trial: The GAS-ART trial
  1. Anders Winther Voldby1,
  2. Anne Albers Aaen2,
  3. Ann Merete Møller3,
  4. Birgitte Brandstrup1
  1. 1 Department of Surgery, Holbaek University Hospital, Holbaek, Denmark
  2. 2 Department of Anaesthesiology, Holbaek University Hospital, Holbaek, Denmark
  3. 3 Department of Anaesthesiology and Intensive Care Medicine, Herlev University Hospital, Holbaek, Denmark
  1. Correspondence to Dr Anders Winther Voldby; anwv{at}regionsjaelland.dk

Abstract

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.

  • fluid therapy
  • perioperative care
  • complications
  • randomised controlled trial
  • outcomes

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Footnotes

  • Contributors BB: Developed the idea, searched the literature, drafted the protocol, conducted the power calculation, framed the intervention and the control treatment, planned the study, collected the data, planned the analysis and interpretation, revised and approved the final protocol. Raised the funds. AMM: Revised the intervention and the control treatment, planned the study, planned the analysis and interpretation, revised and approved the final protocol. AWV: Drafted the present manuscript, refined and revised the drafted protocol, registered the trial at EudraCT, obtaining legislative and ethical approvals, planned the study, revised the intervention, collected the data, revised the analysis and interpretation, revised and approved the final protocol. Responsible for initiating and conducting the trial. Raised the funds. AAA: Revised the drafted protocol, planned the study and intervention, collected the data, revised the analysis and interpretation, revised and approved the final protocol. Responsible for conducting and completion of the trial. Raised the funds. The steering committee consists of BB, AMM, AWV and AAA besides a local investigator from each participating hospital and is responsible for the inclusion and randomisation of patients, the protocol adherence, the data collection and the daily monitoring. The steering committee will critically read the final report and thereby have final authority over the report submitted for publication. The units of Good Clinical Practice monitor the trial at all centres participating.

  • Funding The study is funded by Department of Surgery, Holbaek University Hospital; the Trans-regional Fund between Zealand Region and The Region of South Denmark; the independent research unit of Zealand

    Region

    in Denmark; Axel Muusfeldts fund; Department of Anaesthesiology and Intensive Care, Holbaek University Hospital; Department of Anaesthesiology and Intensive Care, Herlev University Hospital; Department of Anaesthesiology and Intensive Care, Odense University Hospital. The author BB is the sponsor of the GAS-ART trial and the funders have no role in planning, conducting, collection of data or analysis in the trial. The financial support to the project is unrestrained.

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval The trial was approved by the Danish Scientific Ethics Committee (J: SJ-436).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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