Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Surgery

Peking Union Medical College Hospital90 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Lactate Blood Increase Fluid Overload Postoperative Complications

Interventions

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

Applying continuous hemodynamic monitoring system ( LiDCO) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Lactic acid concentrations throughout the perioperative

the change of lactic acid concentrations(mmol/l) throughout the perioperative period

Time frame: from 24 hours before surgery to 24 hours after the surgery

Secondary Outcomes

intraoperative fluid balance, DO2I and predefined moderate or major postoperative complications in 30-day.

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）

Time frame: 30 days after the surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.