Text Size

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

This study is not yet open for participant recruitment.
Verified May 2011 by Mahidol University
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01350076
First received: March 30, 2011
Last updated: May 6, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Adverse Anesthesia Outcome
 Drug: conventional liberal fluid regimen
Drug: restricted fluid regimen
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Liberal VS Goal-directed Intraoperative Fluid Therapy in Pediatric Patients

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Proportion of patients with 5% postoperative weight gain between control group and study group [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Body weight


Secondary Outcome Measures:
  • Postoperative morbidity [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
    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)

  • Amount of intraoperative fluid [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    Amount of intraoperative fluid


Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: crystalloid

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.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350076

Contacts
Contact: Suwannee Suraseranivongse, MD 6681 4087655 sisur@mahidol.ac.th
Contact: Suwannee Suraseranivongse sisur2498@gmail.com

Locations
Thailand
Siriraj Hospital Active, not recruiting
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Suwannee Suraseranivongse, MD Mahidol University
  More Information

No publications provided

Responsible Party: Suwannee Suraseranivongse, Faculty of Medicine Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT01350076     History of Changes
Other Study ID Numbers: Si 511/2010
Study First Received: March 30, 2011
Last Updated: May 6, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
intraoperative fluid
pediatric
goal directed therapy
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

ClinicalTrials.gov processed this record on May 19, 2013