NCT01350076

Liberal Versus Goal-directed Intraoperative Fluid Therapy in Pediatric Patients

Liberal VS Goal-directed Intraoperative Fluid Therapy in Pediatric Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 1 Minute – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adverse Anesthesia Outcome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-06-01
• Completion: 2013-09-01
• First posted: 2011-05-09
• Last updated: 2011-05-09

Locations

1 site across 1 country: Thailand