Liberal Versus Goal-directed Intraoperative Fluid Therapy in Pediatric Patients (GDT)

Mahidol University

Status and phase: Unknown; Phase 2

Conditions: Adverse Anesthesia Outcome

Treatments: Drug: conventional liberal fluid regimen; Drug: restricted fluid regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT01350076

Si 511/2010

Details and patient eligibility

About

The objectives of this study are 1) to investigate the influence of different fluid regimen (Liberal regimen versus Goal directed therapy regimen) on postoperative outcome such as weight gain, delayed gut function recovery, pneumonia and 2) to ascertain the reliability of USCOM monitoring using serum lactate and base deficit as control parameters.

Full description

Liberal regimen = maintenance fluid(4/2/1) + deficit fluid + replacement of third space loss (>,=10ml/kg/h) Goal directed therapy regimen = maintenance fluid + deficit fluid + fluid replaced by hemodynamic monitoring guided.

Enrollment: 40 estimated patients

Sex: All

Ages: 1 minute to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body weight < 15 kg
• Under going major abdominal surgery such as tumor removal, gut obstruction, pull through, etc. under general anesthesia and invasive arterial pressure monitoring if justified
• ASA < or = 3
• Duration of surgery > or = 2 hours

Exclusion criteria

• Cardiopulmonary disease
• Renal insufficiency
• Intraoperative complications such as massive bleeding, severe hypotension, prolonged need for mandatory ventilation
• reoperation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

control group

Active Comparator group

Description:

Control group will receive conventional liberal fluid regimen with crystalloid Liberal fluid regimen = Maintenance fluid + fasting fluid + dehydration + third space loss Maintenance fluid = (4X BW 1-10 kg) + (2X1BW11-20 kg) + (1X BW 0ver 21 kg) Fasting fluid = maintenance fluid X fasting duration

Treatment:

Drug: conventional liberal fluid regimen

study group

Experimental group

Description:

Study group will receive restricted fluid regimen (the same as control group except third space replacement) plus goal directed fluid therapy to maintain adequate CO guided by USCOM as shown in diagram (figure 1). Figure 1 goal directed fluid therapy SVV = Stroke volume variation SVI = Stroke volume index CI = Cardiac index

Treatment:

Drug: restricted fluid regimen