Fluid ResponsivenessNCT02632227
Fluid Responsiveness Using TFU (Transfontanel Ultrasound) in Children With Congenital Heart Disease
An observational study of Fluid Responsiveness, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study was to evaluate the clinical usefulness of TFU (transfontanel ultrasound)for the prediction of fluid responsiveness in children undergoing congenital heart surgery. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Fluid Responsiveness
- What is being tested?
- TFU(transfontanel ultrasound)
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2015to Oct 2017
- Phase
- Observational
- 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 1 year
- All sexes
- No healthy volunteers
- Child
Study population: pediatric patients with congenital heart disease undergoing cardiac surgery
Who may be able to join
- pediatric patients undergoing cardiac surgery
Who cannot join
- preterm closure of anterior fontanelle
- anatomical abnormalities on aortic arch (ex, patent ductus arteriosus)
- presence of intracardiac and extracardiac shunt
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Fluid Responsiveness Using TFU (Transfontanel Ultrasound) in Children With Congenital Heart Disease After Cardiac Surgery
The purpose of this study was to evaluate the clinical usefulness of TFU (transfontanel ultrasound)for the prediction of fluid responsiveness in children undergoing congenital heart surgery.
- Conditions
- Fluid Responsiveness
- Being tested
- TFU(transfontanel ultrasound)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TFU(transfontanel ultrasound)Procedure or surgery
The respiratory variation of the carotid artery blood flow peak velocity was measured using TFU before and after the fluid administration (10ml/kg for 20 min.)
| Study group | Role | What they receive |
|---|---|---|
| Hypovolemia | patients with hypovolemic signs including hypotension, decreased central venous pressure (less than 5mmHg), and decreased urine output Receives: Procedure: TFU(transfontanel ultrasound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in respiratory variation of carotid artery blood flow peak velocity after volume expansion
Measured: before and after fluid administration (20min)
Secondary outcomes (3)
change in cardiac index after volume expansion
Measured: before and after fluid administration (20min)
change in pleth variability index after volume expansion
Measured: before and after fluid administration (20min)
change in respiratory variation of aorta flow blood flow peak velocity after volume expansion
Measured: before and after fluid administration (20min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632227
- Sponsor's protocol ID
- 1511-105-0724
- Status last verified
- Apr 2018
- First submitted
- 13 Dec 2015
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Fluid Responsiveness Using TFU (Transfontanel Ultrasound) in Children With Congenital Heart Disease After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02632227
- Acronym / sponsor ID
- 1511-105-0724
- Conditions
- Fluid Responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 16 Dec 2015 (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 was to evaluate the clinical usefulness of TFU (transfontanel ultrasound)for the prediction of fluid responsiveness in children undergoing congenital heart surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypovolemia | – | Procedure: TFU(transfontanel ultrasound)patients with hypovolemic signs including hypotension, decreased central venous pressure (less than 5mmHg), and decreased urine output |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric patients with congenital heart disease undergoing cardiac surgery
Key inclusion criteria (1 listed)
- pediatric patients undergoing cardiac surgery
Key exclusion criteria (3 listed)
- preterm closure of anterior fontanelle
- anatomical abnormalities on aortic arch (ex, patent ductus arteriosus)
- presence of intracardiac and extracardiac shunt
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 |
|---|---|---|
| TFU(transfontanel ultrasound)The respiratory variation of the carotid artery blood flow peak velocity was measured using TFU before and after the fluid administration (10ml/kg for 20 min.) | Procedure or surgery | Hypovolemia |
Primary outcome
change in respiratory variation of carotid artery blood flow peak velocity after volume expansion
Time frame: before and after fluid administration (20min)
3 secondary outcomes
change in cardiac index after volume expansion
Time frame: before and after fluid administration (20min)
change in pleth variability index after volume expansion
Time frame: before and after fluid administration (20min)
change in respiratory variation of aorta flow blood flow peak velocity after volume expansion
Time frame: before and after fluid administration (20min)
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 5 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 inclusion and 3 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 5 Apr 2018. 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?
change in respiratory variation of carotid artery blood flow peak velocity after volume expansion (time frame: before and after fluid administration (20min)). 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 5 Apr 2018.