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

NCT03164811 | Completed DMC

• 1 other identifier: Si826/2016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Disease

Outcome Measures

Primary Outcomes (1)

• episode of intraoperative hypotension

  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

  intraoperative

Secondary Outcomes (1)

• unit of blood transfusion

  intraoperative and up to 24 hours postoperatively

Study Arms (2)

GDFT group

EXPERIMENTAL

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

Procedure: goal directed fluid therapy

controlled group

OTHER

The carbohydrate drink will not be given. Fluid, blood and blood product administration will be under attending anesthesiologist order.

Other: Controlled

Interventions

goal directed fluid therapy PROCEDURE

pulse pressure variation will be used to as a goal to guide fluid administration in this group

GDFT group

Controlled OTHER

standard fluid treatment by an anesthesiologist

controlled group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1-3
• elective surgery
• thoracic/lumbar spine surgery \>= 3 levels and duration \>= 3 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Spinal Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 24, 2017
• Study Start: April 11, 2017
• Primary Completion: December 30, 2018
• Study Completion: January 30, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)