Liberal Versus Goal-directed Intraoperative Fluid Therapy in Pediatric Patients (GDT)
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| First Received Date ICMJE | March 30, 2011 | ||||||||
| Last Updated Date | May 6, 2011 | ||||||||
| Start Date ICMJE | October 2011 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01350076 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Liberal Versus Goal-directed Intraoperative Fluid Therapy in Pediatric Patients | ||||||||
| Official Title ICMJE | Liberal VS Goal-directed Intraoperative Fluid Therapy in Pediatric Patients | ||||||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Adverse Anesthesia Outcome | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | September 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 5 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Thailand | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01350076 | ||||||||
| Other Study ID Numbers ICMJE | Si 511/2010 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Suwannee Suraseranivongse, Faculty of Medicine Siriraj Hospital, Mahidol University | ||||||||
| Study Sponsor ICMJE | Mahidol University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Mahidol University | ||||||||
| Verification Date | May 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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