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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Mahidol University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01350076
First received: March 30, 2011
Last updated: May 6, 2011
Last verified: May 2011

March 30, 2011
May 6, 2011
October 2011
June 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01350076 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Liberal Versus Goal-directed Intraoperative Fluid Therapy in Pediatric Patients
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Adverse Anesthesia Outcome
  • 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
  • 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
  • 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
    Intervention: Drug: conventional liberal fluid regimen
  • 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

    Intervention: Drug: restricted fluid regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
September 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
up to 5 Years
No
Contact: Suwannee Suraseranivongse, MD 6681 4087655 sisur@mahidol.ac.th
Contact: Suwannee Suraseranivongse sisur2498@gmail.com
Thailand
 
NCT01350076
Si 511/2010
No
Suwannee Suraseranivongse, Faculty of Medicine Siriraj Hospital, Mahidol University
Mahidol University
Not Provided
Principal Investigator: Suwannee Suraseranivongse, MD Mahidol University
Mahidol University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP