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

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)

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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