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

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

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.

Study Overview

• Status: Completed
• Conditions: Spine Disease
• Intervention / Treatment: Procedure: goal directed fluid therapy; Other: Controlled

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GDFT group; 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; pulse pressure variation will be used to as a goal to guide fluid administration in this group
Other: controlled group; The carbohydrate drink will not be given. Fluid, blood and blood product administration will be under attending anesthesiologist order.	Other: Controlled; standard fluid treatment by an anesthesiologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
unit of blood transfusion	all unit of blood transfusion will be record intraoperative and postoperative	intraoperative and up to 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): January 30, 2019

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 2, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: Si826/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No