Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goal-Directed-Therapy (GDT) | Experimental | Besides the basal infusion of crystalloids at 3-6 ml/kg/h, colloids (200 ml) or crystalloids (200 ml) are given over 10 min in the presence of signs of absolute/relative hypovolemia as detected by a fall in cardiac output/stroke volume (CO/SV) or if Pressure Pulse Variation (PVV) or Stroke Volume Variation (SVV) exceeds 10-12%, particularly in the presence. Fluid filling is interrupted when SV fail to increase > 10% (or PVV/SVV =< 10%) Otherwise, vasopressors can be used to achieve appropriate mean arterial pressure (MAP>70 mmHg, within ±20% of baseline). Blood losses are replaced with colloids (1:1) or crystalloids (2:1). |
|
| Restrictive strategy | Active Comparator | Crystalloids are given at a fixed rate of 3-6 ml/kg/h. Otherwise, vasopressors can be used to achieve appropriate MAP (>70 mmHg, within ±20% of baseline). Blood losses are replaced with colloids (1:1) or crystalloids (2:1). Clinicians in charge of the patients are free to use hemodynamic parameters such as PVV or SVV, always attempting to limit the amount of fluid infusion and to maintain normovolemia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goal-directed therapy | Procedure | Optimize CO with additional fluid according to dynamic indices (PPV, SVV, Stroke volume) |
|
| Measure | Description | Time Frame |
|---|---|---|
| composite index of serious postoperative adverse events | early postoperative major outcomes: mortality, cardiovascular, respiratory, renal and infectious complications | from date of surgery till hospital discharge or 30-day postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| body weight changes (kg, postoperative value - preoperative value) | comparison of body weight (preop versus postop value, kg) | from date of surgery till hospital discharge, or 30-day postoperative |
| fluid balance |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marc Licker, MD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Geneva, Department of Anesthesiology | Geneva | 1211 | Switzerland |
Not provided
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D009203 | Myocardial Infarction |
| D001145 | Arrhythmias, Cardiac |
| D006333 | Heart Failure |
| D020521 | Stroke |
| D011014 | Pneumonia |
| D001261 | Pulmonary Atelectasis |
| D055371 | Acute Lung Injury |
| D013530 | Surgical Wound Infection |
| D058186 | Acute Kidney Injury |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074388 | Early Goal-Directed Therapy |
| ID | Term |
|---|---|
| D003422 | Critical Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
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
| Restrictive fluid therapy | Procedure | Keep normovolemia with basal crystalloids infusion (3-6 ml/kg/h) and compensate additional fluid losses with colloids or crystalloids. |
|
amount of fluids (ml) infused, amount of fluid losses
change in body weight
| 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 (%) | from the day before to 3 days after surgery |
| Sequential Organ Failure Assessment (SOFA) | scoring the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems | 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) | intraoperative period, day of surgery |
| survival | patients (family, next of kin, doctor) are contacted by phone or mail | survival 1-3 years after surgery |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D055370 | Lung Injury |
| D014946 | Wound Infection |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |