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

M

Mahidol University

Status

Completed

Conditions

Spine Disease

Treatments

Other: Controlled
Procedure: goal directed fluid therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03164811
Si826/2016

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

GDFT group
Experimental group
Description:
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
Treatment:
Procedure: goal directed fluid therapy
controlled group
Other group
Description:
The carbohydrate drink will not be given. Fluid, blood and blood product administration will be under attending anesthesiologist order.
Treatment:
Other: Controlled

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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