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Perioperative Fluid Management: Goal-Directed Therapy vs. Restrictive Approach, a Randomized Controlled Trial
There is no ideal "cookbook recipe" for fluid prescription that would fit every surgical patient. In this study, the investigators working hypothesis is that the adoption of an integrative algorithm for perioperative fluid and haemodynamic management would improve clinical outcome and reduce hospital resource utilization in noncardiac surgical procedures (major-to-intermediate level of stress. Two intraoperative fluid strategies will be compared: "Restrictive" vs. "goal-directed therapy (GDT)". In the GDT group, haemodynamic information will be obtained by a flow monitoring device coupled with standard heart rate and blood pressure monitoring.
The rationale of minimizing body weight gain and avoiding unnecessary fluid compensation of the "third compartment" is now well justified and achievement of supra-normal oxygen delivery values is likely not necessary in most surgical patients. Therefore,it would be tempting to adopt fluid restriction protocols given the potentials of better wound healing, faster return of bowel function and shorter hospital stay after major surgical procedures. Although dynamic flow indices of volume responsiveness have been validated in critically-ill patients, concerns have been raised regarding the risk of overzealous fluid administration in non-critically-ill patients undergoing elective surgery. To date, RCTs comparing fluid regimen ("liberal" versus "restrictive" or "liberal" versus "GDT") have yielded controversial results with no consensus regarding appropriate fluid administration in the perioperative period. Interestingly, restrictive protocols have been associated with more frequent adverse events (e.g., nausea, vomiting) following minor surgical procedures and concerns have been raised regarding the possibility of tissue hypoperfusion leading to end-organ dysfunction.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University Hospital of Geneva, Department of Anesthesiology
Geneva, Switzerland
Start Date
January 1, 2012
Primary Completion Date
September 1, 2019
Completion Date
September 1, 2019
Last Updated
September 12, 2019
400
ESTIMATED participants
Goal-directed therapy
PROCEDURE
Restrictive fluid therapy
PROCEDURE
Lead Sponsor
University Hospital, Geneva
NCT03881891
NCT03010969
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT03016858