GDFT Based on PPV Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: RCT

Not Applicable

Completed

• Conditions: Spine Disease

• Registration Number: NCT03164811
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-11
• Study First Submitted: 2017-04-24
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-24
• Primary Completion: 2018-12-30
• Study Completion: 2019-01-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-02
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA 1-3
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
episode of intraoperative hypotension	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

Secondary Outcome Measures

Name	Time	Method
unit of blood transfusion	intraoperative and up to 24 hours postoperatively	all unit of blood transfusion will be record intraoperative and postoperative

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok Noi, Bangkok, Thailand