Complication, Postoperative
Conditions
Keywords
operative mortality, myocardial infarct, arrhythmia, heart failure, stroke, pneumonia, atelectasis, acute lung injury, surgical site infection, acute kidney injury, body weight
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURERestrictive fluid therapy
Keep normovolemia with basal crystalloids infusion (3-6 ml/kg/h) and compensate additional fluid losses with colloids or crystalloids.
PROCEDUREGoal-directed therapy
Optimize CO with additional fluid according to dynamic indices (PPV, SVV, Stroke volume)
Sponsors
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Patients, clinical care givers and assessors are blinded to the the treatment (GDT or restrictive). Sealed enveloppes contain the patient' identification number. A person not involved in the study prepare the enveloppes with the identification number. Investigators who are assessing the postoperative study outcomes are blinded to the treatment arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patient * elective noncardiac surgery (moderate-high-risk) lasting \> 2h hours (, gastrectomy, pancreatectomy, nephrectomy, radical cystectomy, hepatic resection, open colonic or rectal surgery)
Exclusion criteria
* end-stage organ failure (hemofiltration/dialysis; Child-Pugh class C or MELD score \>22; predicted forced expiratory volume \< 30%, severe heart failure) * life expectancy \< 24h * psychiatric disorders or unability to give independent consent to the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| composite index of serious postoperative adverse events | from date of surgery till hospital discharge or 30-day postoperative | early postoperative major outcomes: mortality, cardiovascular, respiratory, renal and infectious complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body weight changes (kg, postoperative value - preoperative value) | from date of surgery till hospital discharge, or 30-day postoperative | comparison of body weight (preop versus postop value, kg) |
| fluid balance | intra-operative and first 24hours after surgery | amount of fluids (ml) infused, amount of fluid losses change in body weight |
| Acute Kidney Injury based on RIFLE | from the day before to 3 days after surgery | measurements of creatinine (preoperative, postoperative day 1, 2, 3 after surgery) and assessing the changes in glomerular filtration rate (%) |
| Sequential Organ Failure Assessment (SOFA) | from date of surgery till hospital discharge, up to 15 weeks after date of surgery | scoring the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems |
| tissue oximetry (%) | intraoperative period, day of surgery | Monitoring of oxygen delivery/utilization in the brain area with near-infra-red spectroscopy (NIRS) |
| survival | survival 1-3 years after surgery | patients (family, next of kin, doctor) are contacted by phone or mail |
Countries
Switzerland
Outcome results
None listed