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OpenTrials
Completed

NCT Number: NCT03164811

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

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.

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Key information

Conditions

Spine Disease Bone Diseases Musculoskeletal Diseases Spinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

goal directed fluid therapy

Procedure

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

Controlled

Other

standard fluid treatment by an anesthesiologist

Primary outcomes

  1. 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

Secondary outcomes

  1. unit of blood transfusion

    Time frame: intraoperative and up to 24 hours postoperatively

    all unit of blood transfusion will be record intraoperative and postoperative

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 24, 2017
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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