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Liberal Versus Goal-directed Intraoperative Fluid Therapy in Pediatric Patients

NCT01350076 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-05-09

No results posted yet for this study

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.

Conditions

  • Adverse Anesthesia Outcome

Interventions

DRUG

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

DRUG

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

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Suwannee Suraseranivongse, MD · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-06-30
Completion
2013-09-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01350076 on ClinicalTrials.gov