Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Surgery

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Postoperative Complications; Fluid Overload; Lactate Blood Increase

Treatments: Other: Applying goal-directed fluid therapy by continuous hemodynamic monitoring system (LiDCO）

Study type: Interventional

Funder types: Other

Identifiers

NCT03974906

PUMCH-GDT2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 60 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

GDT group

Experimental group

Description:

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.

Treatment:

Other: Applying goal-directed fluid therapy by continuous hemodynamic monitoring system (LiDCO）

Control group

No Intervention group

Description:

Patients in the control group received conventional fluid therapy, decided by the attending anesthesiologists based on the patient's hemodynamic condition and responses, to maintain MAP \>65 mm Hg, heart rate 50-100 bpm, and urine output \>0.5 ml/kg/h.