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

Spine Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164811
• Other study ID #: Si826/2016
• Status: Completed
• Phase: N/A
• Start date: April 11, 2017
• Est. completion date: January 30, 2019

Study information

• Verified date: February 2020
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Diseases
• Spine Disease

Intervention

Procedure:
• goal directed fluid therapy
pulse pressure variation will be used to as a goal to guide fluid administration in this group

Other:
• Controlled
standard fluid treatment by an anesthesiologist

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	unit of blood transfusion	all unit of blood transfusion will be record intraoperative and postoperative	intraoperative and up to 24 hours postoperatively