Liberal Versus Goal-directed Intraoperative Fluid Therapy in Pediatric Patients

Adverse Anesthesia Outcome Clinical Trial

— GDT  

Official title:

Liberal VS Goal-directed Intraoperative Fluid Therapy in Pediatric Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01350076
• Other study ID #: Si 511/2010
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 30, 2011
• Last updated: May 6, 2011
• Start date: October 2011
• Est. completion date: September 2013

Study information

• Verified date: May 2011
• Source: Mahidol University
• Contact: Suwannee Suraseranivongse, MD
• Phone: 6681 4087655
• Email: sisur[@]mahidol.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adverse Anesthesia Outcome

Intervention

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
• 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

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with 5% postoperative weight gain between control group and study group	Body weight	24 hours	Yes
Secondary	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	Yes
Secondary	Amount of intraoperative fluid	Amount of intraoperative fluid	1 day	Yes