Liberal Versus Goal-directed Intraoperative Fluid Therapy in Pediatric Patients

Phase 2

• Conditions: Adverse Anesthesia Outcome
• Interventions: Drug: conventional liberal fluid regimen; Drug: restricted fluid regimen

• Registration Number: NCT01350076
• Lead Sponsor: Mahidol University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-03-30
• Status Verified: 2011-05
• Study First Submitted QC: 2011-05-06
• Last Update Submitted: 2011-05-06
• Study First Posted: 2011-05-09
• Last Update Posted: 2011-05-09
• Study Start: 2011-10
• Primary Completion: 2013-06
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	conventional liberal fluid regimen	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
study group	restricted fluid regimen	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

Primary Outcome Measures

Name	Time	Method
Proportion of patients with 5% postoperative weight gain between control group and study group	24 hours	Body weight

Secondary Outcome Measures

Name	Time	Method
Amount of intraoperative fluid	1 day	Amount of intraoperative fluid
Postoperative morbidity	4 days	Postoperative morbidity: lung (new postoperative infiltration), prolonged ileus means inability to feed in postoperative day 4, kidney ( increase BUN, Cr), tissue hypoxia (wound infection, anastomotic leakage)

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand