Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Surgery

Not Applicable

Completed

• Conditions: Lactate Blood Increase; Postoperative Complications; Fluid Overload
• Interventions: Other: Applying goal-directed fluid therapy by continuous hemodynamic monitoring system (LiDCO）

• Registration Number: NCT03974906
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2017-09-30
• Study Completion: 2018-06-01
• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-05
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-13
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GDT group	Applying goal-directed fluid therapy by continuous hemodynamic monitoring system (LiDCO）	The fluid in GDT group (Goal-directed fluid therapy) will be administered based upon real-time monitoring stroke volume variation and cardiac output achieved by the LiDCO monitoring system.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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）

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China