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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
400
Optimize CO with additional fluid according to dynamic indices (PPV, SVV, Stroke volume)
Keep normovolemia with basal crystalloids infusion (3-6 ml/kg/h) and compensate additional fluid losses with colloids or crystalloids.
University Hospital of Geneva, Department of Anesthesiology
Geneva, Switzerland
composite index of serious postoperative adverse events
early postoperative major outcomes: mortality, cardiovascular, respiratory, renal and infectious complications
Time frame: from date of surgery till hospital discharge or 30-day postoperative
body weight changes (kg, postoperative value - preoperative value)
comparison of body weight (preop versus postop value, kg)
Time frame: from date of surgery till hospital discharge, or 30-day postoperative
fluid balance
amount of fluids (ml) infused, amount of fluid losses change in body weight
Time frame: intra-operative and first 24hours after surgery
Acute Kidney Injury based on RIFLE
measurements of creatinine (preoperative, postoperative day 1, 2, 3 after surgery) and assessing the changes in glomerular filtration rate (%)
Time frame: from the day before to 3 days after surgery
Sequential Organ Failure Assessment (SOFA)
scoring the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems
Time frame: from date of surgery till hospital discharge, up to 15 weeks after date of surgery
tissue oximetry (%)
Monitoring of oxygen delivery/utilization in the brain area with near-infra-red spectroscopy (NIRS)
Time frame: intraoperative period, day of surgery
survival
patients (family, next of kin, doctor) are contacted by phone or mail
Time frame: survival 1-3 years after surgery
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