Fluid Overload, Lactate Blood Increase, Postoperative Complications
Conditions
Keywords
goal-directed fluid therapy, lactate acid level, postoperative complications, elderly patient, prone position, intraoperative hemodynamics
Brief summary
This is a randomized controlled clinical trial which investigates whether goal directed fluid therapy( GDT ) would show the evidence of benefit from GDT in terms of lactate kinetics then may reduce postoperative complications in patients undergoing spine surgery, especially in prone positions.
Detailed description
This is a single-center, randomized controlled clinical trial. Patients aged \> 60 undergoing lumbar decompression surgery will be randomly assigned to either a GDT ( goal directed fluid therapy) group or a control group, who received conventional anesthesiologist-directed fluid therapy. Perioperative lactic acid concentrations with 7 different time point, intraoperative fluid balance and postoperative complications from admittance to 30 days after surgery were recorded. This RCT is conducted to show the evidence of benefit from GDT in terms of lactate kinetics then may reduce postoperative complications in patients undergoing spine surgery, especially in prone positions.
Interventions
OTHERApplying goal-directed fluid therapy by continuous hemodynamic monitoring system (LiDCO）
Applying continuous hemodynamic monitoring system ( LiDCO) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Patients were assigned to one of the two groups (control group and GDT group) using a computer-generated randomization scheme.Allocation concealment was obtained using number labeled opaque envelopes that were opened just before the surgery. Data were collected by persons unaware of treatment allocation.
Eligibility
Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* age \> 60 years, American Society of Anesthesiologists score II-III, and expected duration of operation \> 2 h
Exclusion criteria
* Patients with severe cardiac arrhythmia (which would affect the accuracy of stroke volume variation as an indicator of fluid responsiveness), vascular disease (which would prohibit radial artery cannulation), and mental disorder were excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lactic acid concentrations throughout the perioperative | from 24 hours before surgery to 24 hours after the surgery | the change of lactic acid concentrations(mmol/l) throughout the perioperative period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative fluid balance, DO2I and predefined moderate or major postoperative complications in 30-day. | 30 days after the surgery | Intraoperative fluid balance include the volumes of crystalloids(ml), colloids(ml) and total volumes of intravenous fluids and output of the patients during surgery. Derived DO2I(oxygen delivery index, ml/min·m2) variables were calculated according to standard formulae. The incidence of complications related to surgeries 30 days postoperatively. The complications include pneumonia, pulmonary embolism, cardiovascular events (myocardial infarction, heart failure), wound infection, gastrointestinal bleeding,nausea and vomitting，postoperative hemorrhage, ileus, deep venous thrombosis, cerebral infarction, cerebral embolism, cerebral hemorrhage, renal insufficiency and failure. Those complications are defined strictly to the reference published in 2009 New England Journal of Medicine （N Engl J Med. 2009 Oct 1;361:1368-75） |
Countries
China
Outcome results
None listed