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

February 2, 2020 updated by: Mahidol University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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
intraoperative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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