Fluid ResponsivenessNCT01364103
Study About Predicting Fluid Responsiveness in Children Undergoing Neurosurgery
A study testing volume expansion in people with Fluid Responsiveness, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
The purpose of this study is to evaluate static and dynamic parameters, echocardiographic parameters, and pleth variability index for predicting fluid responsiveness in children. Children who need volume expansion will receive colloid 10 mL/kg. Read more about this study
- Who is it for?
- Ages Up to 8 years
- Conditions the study is for
- Fluid Responsiveness
- What is being tested?
- volume expansion
- How many people
- 33 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Feb 2011to May 2011
- Phase
- Interventional
- 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 Up to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- neurosurgery under general anesthesia
- < 8 years old
Who cannot join
- cardiac disease
- pulmonary, renal and hepatic disease
- infectious disease
- hematologic and muscular disease
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul national university hospital
Seoul, 110-744
Seoul national university hospital
Seoul
About this study
The purpose of this study is to evaluate static and dynamic parameters, echocardiographic parameters, and pleth variability index for predicting fluid responsiveness in children. Children who need volume expansion will receive colloid 10 mL/kg. Blood pressure, heart rate, central venous pressure, systolic pressure variation, pulse pressure variation, delta down, aortic blood flow velocity variation, inferior vena cava diameter variation, and pleth variability index will be measure before and after volume expansion. Patients will be classified as responders to volume loading if stoke volume index increase by at least 15%.
- Conditions
- Fluid Responsiveness
- Being tested
- volume expansion
- Keywords
- pulse pressure variation, systolic pressure variation, central venous pressure, aortic blood flow velocity variation, pleth variability index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volume expansionOther
fluid loading of 10 mL/kg colloid (voluven)
What is being measured
The primary outcome is the main question the study is designed to answer.
stoke volume index
Volume loading will be performed for 20 minutes. Stroke volume will be meausred before and after volume expansion
Measured: before and after volume loading (20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fluid ResponsivenessStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, MD, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364103
- Sponsor's protocol ID
- H-1012-118-345
- Status last verified
- Jan 2012
- First submitted
- 24 May 2011
- Last updated
- 2 Feb 2012
- Results posted
- No
Publications
Byon HJ, Lim CW, Lee JH, Park YH, Kim HS, Kim CS, Kim JT. Prediction of fluid responsiveness in mechanically ventilated children undergoing neurosurgery. Br J Anaesth. 2013 Apr;110(4):586-91. doi: 10.1093/bja/aes467. Epub 2012 Dec 18.
PubMed 23250892
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study About Predicting Fluid Responsiveness in Children Undergoing Neurosurgery
- ClinicalTrials.gov ID
- NCT01364103
- Acronym / sponsor ID
- H-1012-118-345
- Conditions
- Fluid Responsiveness
- Keywords
- pulse pressure variation, systolic pressure variation, central venous pressure, aortic blood flow velocity variation, pleth variability index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 2 Jun 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 purpose of this study is to evaluate static and dynamic parameters, echocardiographic parameters, and pleth variability index for predicting fluid responsiveness in children. Children who need volume expansion will receive colloid 10 mL/kg. Blood pressure, heart rate, central venous pressure, systolic pressure variation, pulse pressure variation, delta down, aortic blood flow velocity variation, inferior vena cava diameter variation, and pleth variability index will be measure before and after volume expansion. Patients will be classified as responders to volume loading if stoke volume index increase by at least 15%.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- Up to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- neurosurgery under general anesthesia
- < 8 years old
Key exclusion criteria (4 listed)
- cardiac disease
- pulmonary, renal and hepatic disease
- infectious disease
- hematologic and muscular disease
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 |
|---|---|---|
| volume expansionfluid loading of 10 mL/kg colloid (voluven) | Other | – |
Primary outcome
stoke volume index
Time frame: before and after volume loading (20 minutes)
Volume loading will be performed for 20 minutes. Stroke volume will be meausred before and after volume expansion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
- Derived from this study: PubMed 23250892Byon HJ, Lim CW, Lee JH, Park YH, Kim HS, Kim CS, Kim JT. Prediction of fluid responsiveness in mechanically ventilated children undergoing neurosurgery. Br J Anaesth. 2013 Apr;110(4):586-91. doi: 10.1093/bja/aes467. Epub 2012 Dec 18.
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Inferior Vena Cava Versus Subclavian Vein Collapsibility for Predicting Fluid Responsiveness in Trauma Hemorrhagic Shock
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This Study Compares Two Noninvasive Dynamic Tools: Lung Ultrasound and Transthoracic Echocardiography Using LVOT VTI. It Aims to Measure the Sensitivity and Specificity of LUS in Guiding Fluid Resuscitation and Early Detection of Fluid Responsiveness and to Prevent Volume Overload
Septic Shock, Fluid Reponsiveness
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.
Jin-Tae Kim, MD, PhD study chair
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing volume expansion in people with Fluid Responsiveness, run by Seoul National University Hospital at 2 sites in South Korea.
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 2 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: finished, as of the sponsor's last update on 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stoke volume index (time frame: before and after volume loading (20 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01364103, which also lists 1 linked publication.
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 2 Feb 2012.