Adverse Anesthesia OutcomePhase 2GDTNCT01350076
Liberal Versus Goal-directed Intraoperative Fluid Therapy in Pediatric Patients
A Phase 2 study testing conventional liberal fluid regimen and restricted fluid regimen in people with Adverse Anesthesia Outcome, run by Mahidol University at 1 site in Thailand.
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… Read more about this study
- Who is it for?
- Ages 1 minute to 5 years
- Conditions the study is for
- Adverse Anesthesia Outcome
- What is being tested?
- conventional liberal fluid regimen and restricted fluid regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2011to Sep 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Cardiopulmonary disease
- Renal insufficiency
- Intraoperative complications such as massive bleeding, severe hypotension, prolonged need for mandatory ventilation
- reoperation
Trial locations and contacts
1 site in 1 country.
Suwannee Suraseranivongse contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Adverse Anesthesia Outcome
- Being tested
- conventional liberal fluid regimen, restricted fluid regimen
- Keywords
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional liberal fluid regimenDrug
Also called crystalloid
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 regimenDrug
Also called crystalloid
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
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | 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 Receives: Drug: conventional liberal fluid regimen |
| study group | Experimental | 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 Receives: Drug: restricted fluid regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with 5% postoperative weight gain between control group and study group
Body weight
Measured: 24 hours
Secondary outcomes (2)
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)
Measured: 4 days
Amount of intraoperative fluid
Amount of intraoperative fluid
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Anesthesia OutcomeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Suwannee Suraseranivongse, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350076
- Sponsor's protocol ID
- Si 511/2010
- Acronym
- GDT
- Status last verified
- May 2011
- First submitted
- 30 Mar 2011
- Last updated
- 9 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liberal VS Goal-directed Intraoperative Fluid Therapy in Pediatric Patients
- ClinicalTrials.gov ID
- NCT01350076
- Acronym / sponsor ID
- GDT / Si 511/2010
- Conditions
- Adverse Anesthesia Outcome
- Keywords
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 9 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: conventional liberal fluid regimenControl 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 |
| study group | Experimental | Drug: restricted fluid regimenStudy 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 |
Who may qualify
- Ages
- 1 minute to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Cardiopulmonary disease
- Renal insufficiency
- Intraoperative complications such as massive bleeding, severe hypotension, prolonged need for mandatory ventilation
- reoperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional liberal fluid regimenAlso: crystalloidControl 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 | control group |
| restricted fluid regimenAlso: crystalloidStudy 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 | study group |
Primary outcome
Proportion of patients with 5% postoperative weight gain between control group and study group
Time frame: 24 hours
Body weight
2 secondary outcomes
Postoperative morbidity
Time frame: 4 days
Amount of intraoperative fluid
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suwannee Suraseranivongse contact
Suwannee Suraseranivongse, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing conventional liberal fluid regimen and restricted fluid regimen in people with Adverse Anesthesia Outcome, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suwannee Suraseranivongse, MD (6681 4087655, sisur@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with 5% postoperative weight gain between control group and study group (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2011.