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

Not Applicable

Completed

• Conditions: Spine Disease
• Interventions: Procedure: goal directed fluid therapy; Other: Controlled

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GDFT group	goal directed fluid therapy	The GDFT group will receive 400 ml of 12.5% carbohydrate drink after 6 pm until the bed time in the day before surgery and 200 ml in the morning of the surgery day. Acetate ringer solution will be start at 7:00. After induction PPV will be measure and fluid bolus 200 ml in 10 minutes will be given if PPV \>13 before prone position. During the operation, the patient in GDFT group will receipt fluid therapy according to acceptable PPV
controlled group	Controlled	The carbohydrate drink will not be given. Fluid, blood and blood product administration will be under attending anesthesiologist order.

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