Clinical trial NCT03974906: Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Surgery
Official title: Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Decompression Surgery in the Prone Position: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactate Blood Increase
Fluid Overload
Postoperative Complications
Keywords: goal-directed fluid therapy
lactate acid level
postoperative complications
elderly patient
prone position
intraoperative hemodynamics
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lactic acid concentrations throughout the perioperative
timeFrame: from 24 hours before surgery to 24 hours after the surgery
Secondary outcomes:
measure: intraoperative fluid balance, DO2I and predefined moderate or major postoperative complications in 30-day.
timeFrame: 30 days after the surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
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citation: Bacchin MR, Ceria CM, Giannone S, Ghisi D, Stagni G, Greggi T, Bonarelli S. Goal-Directed Fluid Therapy Based on Stroke Volume Variation in Patients Undergoing Major Spine Surgery in the Prone Position: A Cohort Study. Spine (Phila Pa 1976). 2016 Sep 15;41(18):E1131-E1137. doi: 10.1097/BRS.0000000000001601.
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