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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03164811
Enrollment
60
Registered
2017-05-24
Start date
2017-04-11
Completion date
2019-01-30
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spine Disease

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.

Interventions

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

standard fluid treatment by an anesthesiologist

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
episode of intraoperative hypotensionintraoperativeBlood 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

MeasureTime frameDescription
unit of blood transfusionintraoperative and up to 24 hours postoperativelyall unit of blood transfusion will be record intraoperative and postoperative

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026