Fluid ResponsivenessNCT01996956
Prediction of Fluid Responsiveness by NICOM (Non-invasive Cardiac Output Monitoring) in Children With Congenital Heart Disease After Cardiac Surgery
A study testing volume expansion in people with Fluid Responsiveness, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the ability of fluid responsiveness by stroke volume variation value of NICOM(Noninvasive cardiac output monitor)system during congenital cardiac surgery. Read more about this study
- Who is it for?
- Ages 1 day to 5 years
- Conditions the study is for
- Fluid Responsiveness
- What is being tested?
- volume expansion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to Oct 2013
- 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 1 day to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- congenital cardiac surgery
- < 6 years old
- who were required the evaluation by transesophageal echocardiography
Who cannot join
- right heart failure
- supported by more than 2 inotropic agents
- reduced kidney function
- any valvar stenosis
- moderate or severe tricuspid regurgitation
- single ventricle
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the ability of fluid responsiveness by stroke volume variation value of NICOM(Noninvasive cardiac output monitor)system during congenital cardiac surgery.
- Conditions
- Fluid Responsiveness
- Being tested
- volume expansion
- Keywords
- stroke volume variation,, cardiac output,, fluid responsiveness,, noninvasive cardiac output monitor
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 or blood product
| Study group | Role | What they receive |
|---|---|---|
| Volume loading | Other | Not described Receives: Other: volume expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke volume index
Volume loading was performed for 20 minutes. Stroke volume measured before and after volume expansion using transesophageal echocardiography. And, stroke volume variation of NICOM monitor was recorded before fluid loading.
Measured: before and after volume loading (20 min)
Secondary outcomes (1)
Cardiac index
Cardiac index measured by transesophageal echocardiography and NICOM monitor were compared before and after fluid loading for 20 min.
Measured: before and after fluid loading (20 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2013
- Study completionOct 2013
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
- 30 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
- NCT01996956
- Sponsor's protocol ID
- H-1303-114-478
- Status last verified
- Nov 2013
- First submitted
- 17 Nov 2013
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee JH, No HJ, Song IK, Kim HS, Kim CS, Kim JT. Prediction of fluid responsiveness using a non-invasive cardiac output monitor in children undergoing cardiac surgery. Br J Anaesth. 2015 Jul;115(1):38-44. doi: 10.1093/bja/aev109. Epub 2015 Apr 29.
PubMed 25926311
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Fluid Responsiveness by NICOM (Non-invasive Cardiac Output Monitoring) in Children With Congenital Heart Disease After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01996956
- Acronym / sponsor ID
- H-1303-114-478
- Conditions
- Fluid Responsiveness
- Keywords
- stroke volume variation,, cardiac output,, fluid responsiveness,, noninvasive cardiac output monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 27 Nov 2013 (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 the ability of fluid responsiveness by stroke volume variation value of NICOM(Noninvasive cardiac output monitor)system during congenital cardiac surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volume loading | Other | Other: volume expansion |
Who may qualify
- Ages
- 1 day to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- congenital cardiac surgery
- < 6 years old
- who were required the evaluation by transesophageal echocardiography
Key exclusion criteria (6 listed)
- right heart failure
- supported by more than 2 inotropic agents
- reduced kidney function
- any valvar stenosis
- moderate or severe tricuspid regurgitation
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 or blood product | Other | Volume loading |
Primary outcome
stroke volume index
Time frame: before and after volume loading (20 min)
Volume loading was performed for 20 minutes. Stroke volume measured before and after volume expansion using transesophageal echocardiography. And, stroke volume variation of NICOM monitor was recorded before fluid loading.
1 secondary outcome
Cardiac index
Time frame: before and after fluid loading (20 min)
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 27 Nov 2013.
- Derived from this study: PubMed 25926311Lee JH, No HJ, Song IK, Kim HS, Kim CS, Kim JT. Prediction of fluid responsiveness using a non-invasive cardiac output monitor in children undergoing cardiac surgery. Br J Anaesth. 2015 Jul;115(1):38-44. doi: 10.1093/bja/aev109. Epub 2015 Apr 29.
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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.
Jin-Tae Kim, MD, PhD study chair
Seoul National University Hospital
1 site 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 1 site 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 3 inclusion and 6 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 27 Nov 2013. 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 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?
stroke volume index (time frame: before and after volume loading (20 min)). 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 NCT01996956, 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 27 Nov 2013.