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Clinical Trials/NCT01350076
NCT01350076
Unknown
Phase 2

Liberal VS Goal-directed Intraoperative Fluid Therapy in Pediatric Patients

Mahidol University1 site in 1 country40 target enrollmentOctober 2011

Overview

Phase
Phase 2
Intervention
conventional liberal fluid regimen
Conditions
Adverse Anesthesia Outcome
Sponsor
Mahidol University
Enrollment
40
Locations
1
Primary Endpoint
Proportion of patients with 5% postoperative weight gain between control group and study group
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
September 2013
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Arms & Interventions

control group

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

Intervention: conventional liberal fluid regimen

study group

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

Intervention: restricted fluid regimen

Outcomes

Primary Outcomes

Proportion of patients with 5% postoperative weight gain between control group and study group

Time Frame: 24 hours

Body weight

Secondary Outcomes

  • Amount of intraoperative fluid(1 day)
  • Postoperative morbidity(4 days)

Study Sites (1)

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