Goal Directed Fluid Therapy Based on Pulse Pressure Variation Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: a Randomized Controlled Trial

Mahidol University1 site in 1 country60 target enrollmentApril 11, 2017

ConditionsSpine Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spine Disease
Sponsor: Mahidol University
Enrollment: 60
Locations: 1
Primary Endpoint: episode of intraoperative hypotension
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The investigators will do the Goal directed fluid therapy by protocolized fluid management in the experimental group, using PPV to guide the fluid administration, compare with standard fluid management in patients undergoing complex spine surgery.

Registry

clinicaltrials.gov

Start Date

April 11, 2017

End Date

January 30, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mahidol University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•elective surgery
•thoracic/lumbar spine surgery \>= 3 levels and duration \>= 3 hours

Exclusion Criteria

•Cr \>2 mg/dl or eGFR \< 60 ml/min
•coronary artery disease, congestive heart failure or cardiac arrhythmia
•BMI \>30 kg/m2
•hemodynamic unstable, preoperatively
•uncontrolled hypertension
•respiratory system compliance \< 30 ml/cmH2O

Outcomes

Primary Outcomes

episode of intraoperative hypotension

Time Frame: intraoperative

Blood pressure will be record continuously using arterial catheter in both group. Number of participants and episode of hypotension (defined as SBP \< 90 mmHg or MAP \< 60 mmHg or decrease of SPB \>= 25% from baseline for 5 minutes or need vasopressor) therapy