Liberal Versus Goal-directed Intraoperative Fluid Therapy in Pediatric Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Liberal VS Goal-directed Intraoperative Fluid Therapy in Pediatric Patients

Conditions
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Adverse Anesthesia Outcome

Intervention / Treatment
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* Drug: conventional liberal fluid regimen
* Drug: restricted fluid regimen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>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 | Drug: conventional liberal fluid regimen<br>* 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<br>* Other names: crystalloid;|
| Experimental: study group<br>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 | Drug: restricted fluid regimen<br>* 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<br>* Other names: crystalloid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with 5% postoperative weight gain between control group and study group | Body weight | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morbidity | 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) | 4 days | 
| Amount of intraoperative fluid | Amount of intraoperative fluid | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraoperative fluid, pediatric, goal directed therapy, pediatric with major abdominal surgery, ASA less than or equal to 3, Duration of surgery less than 2 hours, Body weight more than or equal to 15 kg