Liberal Versus Goal-directed Intraoperative Fluid Therapy in Pediatric Patients (GDT)

Liberal VS Goal-directed Intraoperative Fluid Therapy in Pediatric Patients

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.

Study Overview

• Status: Unknown
• Conditions: Adverse Anesthesia Outcome
• Intervention / Treatment: Drug: conventional liberal fluid regimen; Drug: restricted fluid regimen

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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; Other Names: crystalloid
Experimental: 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	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; Other Names: crystalloid

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Suwannee Suraseranivongse, MD, Mahidol University

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: May 6, 2011
• First Posted (Estimate): May 9, 2011

Study Record Updates

• Last Update Posted (Estimate): May 9, 2011
• Last Update Submitted That Met QC Criteria: May 6, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: pediatric; goal directed therapy; intraoperative fluid; 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
• Other Study ID Numbers: Si 511/2010