Congenital Heart DiseaseNCT02287753
Relationship Between Parameters of VOT Using NIRS and Clinical Outcomes in Pediatric Cardiac Surgery
A study testing vascular occlusion test using Pediatric SomaSensor for INVOS 5100C in people with Congenital Heart Disease, 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 vascular occlusion test (VOT) during cardiac surgery to predict postoperative outcomes in pediatric patients. Read more about this study
- Who is it for?
- Ages Up to 8 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- vascular occlusion test using Pediatric SomaSensor for INVOS 5100C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Dec 2016
- 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
- Pediatric patients aged under 8 years old who are scheduled for cardiac surgery
Who cannot join
- Skin disease
- Skin preparation involving thigh
- Peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Parameters of Vascular Occlusion Test Using Near Infrared Spectroscopy and Clinical Parameters & Outcomes in Pediatric Cardiac Surgery
The purpose of this study is to evaluate the ability of vascular occlusion test (VOT) during cardiac surgery to predict postoperative outcomes in pediatric patients.
Read the detailed description
After induction of anesthesia, pediatric SomaSensor for INVOS 5100C is attached at calf muscle and non-invasive blood pressure cuff is applied to ipsilateral thigh. VOT is performed as: after baseline oxygen saturation value is recorded, cuff pressure is rapidly increased to 30 mmHg over than systolic blood pressure. After 3 minutes of ischemic time, cuff pressure is rapidly decreased. It is performed at 3 time periods : before start of operation, during cardiopulmonary bypass, and after weaning from cardiopulmonary bypass. Postoperative outcome variables are recorded after surgery : major adverse event, use of inotropic and vasoactive drugs, duration of mechanical ventilation and ICU stay. The relationship between the results of VOT and postoperative outcome will be investigated.
- Conditions
- Congenital Heart Disease
- Being tested
- vascular occlusion test using Pediatric SomaSensor for INVOS 5100C
- Keywords
- vascular occlusion test, near infrared spectroscopy
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vascular occlusion test using Pediatric SomaSensor for INVOS 5100COther
Pediatric SomaSensor for INVOS 5100C is attached at calf muscle and non-invasive blood pressure cuff is applied to ipsilateral thigh. VOT is performed as: after baseline oxygen saturation value is recorded, cuff pressure is rapidly increased to 30 mmHg over than systolic blood pressure. After 3 minutes of ischemic time, cuff pressure is rapidly decreased. It is performed at 3 time periods : before start of operation, during cardiopulmonary bypass, and after weaning from cardiopulmonary bypass.
| Study group | Role | What they receive |
|---|---|---|
| Vascular occlusion test (VOT) | Experimental | Pediatric patients aged under 8 years old are enrolled in this study. VOT is performed in 3 times : after induction of anesthesia, during cardiopulmonary bypass (CPB) for main surgical procedure and after weaning from CPB. The relationship between postoperative outcome variables and the dynamic parameters from VOT, such as desaturation and reoxygenation rate, and reactive hyperemic area, will be evaluated. Receives: Other: vascular occlusion test using Pediatric SomaSensor for INVOS 5100C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse event
Major adverse event is defined as cardiac compression, re-sternotomy because of hemodynamic instability, ECMO support, Cr> 2mg/dL, cerebral hemorrhage or infarct and mortality.
Measured: up to 1 years after surgery
Secondary outcomes (2)
Use of inotropic and vasoactive drugs
Use of inotropic and vasoactive drugs is evaluated using vasoactive-Inotropic scores (VIS). VIS is calculated as: dopamine dose (㎍/kg/min) + dobutamine dose (㎍/kg/min) + 100 x epinephrine dose (㎍/kg/min) + 10 x milrinone dose (㎍/kg/min) + 10,000 x vasopressin dose (U/kg/min) + 100 x norepinephrine dose (㎍/kg/min).(7) VIS at 0, 24, 48, and 72 hours after surgery ended are collected in all patients.
Measured: up to 1 years after surgery
Length of mechanical ventilation time and ICU stay
Measured: up to 1 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2016
- Study completionDec 2016
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 Congenital Heart DiseaseStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 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, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287753
- Sponsor's protocol ID
- H-1309-095-522
- Status last verified
- Apr 2017
- First submitted
- 6 Nov 2014
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee JH, Jang YE, Song IK, Kim EH, Kim HS, Kim JT. Near-Infrared Spectroscopy and Vascular Occlusion Test for Predicting Clinical Outcome in Pediatric Cardiac Patients: A Prospective Observational Study. Pediatr Crit Care Med. 2018 Jan;19(1):32-39. doi: 10.1097/PCC.0000000000001386.
PubMed 29140967
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Parameters of Vascular Occlusion Test Using Near Infrared Spectroscopy and Clinical Parameters & Outcomes in Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02287753
- Acronym / sponsor ID
- H-1309-095-522
- Conditions
- Congenital Heart Disease
- Keywords
- vascular occlusion test, near infrared spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Nov 2014 (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 vascular occlusion test (VOT) during cardiac surgery to predict postoperative outcomes in pediatric patients.
Detailed description
After induction of anesthesia, pediatric SomaSensor for INVOS 5100C is attached at calf muscle and non-invasive blood pressure cuff is applied to ipsilateral thigh. VOT is performed as: after baseline oxygen saturation value is recorded, cuff pressure is rapidly increased to 30 mmHg over than systolic blood pressure. After 3 minutes of ischemic time, cuff pressure is rapidly decreased. It is performed at 3 time periods : before start of operation, during cardiopulmonary bypass, and after weaning from cardiopulmonary bypass. Postoperative outcome variables are recorded after surgery : major adverse event, use of inotropic and vasoactive drugs, duration of mechanical ventilation and ICU stay. The relationship between the results of VOT and postoperative outcome will be investigated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vascular occlusion test (VOT) | Experimental | Other: vascular occlusion test using Pediatric SomaSensor for INVOS 5100CPediatric patients aged under 8 years old are enrolled in this study. VOT is performed in 3 times : after induction of anesthesia, during cardiopulmonary bypass (CPB) for main surgical procedure and after weaning from CPB. The relationship between postoperative outcome variables and the dynamic parameters from VOT, such as desaturation and reoxygenation rate, and reactive hyperemic area, will be evaluated. |
Who may qualify
- Ages
- Up to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients aged under 8 years old who are scheduled for cardiac surgery
Key exclusion criteria (3 listed)
- Skin disease
- Skin preparation involving thigh
- Peripheral vascular 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 |
|---|---|---|
| vascular occlusion test using Pediatric SomaSensor for INVOS 5100CPediatric SomaSensor for INVOS 5100C is attached at calf muscle and non-invasive blood pressure cuff is applied to ipsilateral thigh. VOT is performed as: after baseline oxygen saturation value is recorded, cuff pressure is rapidly increased to 30 mmHg over than systolic blood pressure. After 3 minutes of ischemic time, cuff pressure is rapidly decreased. It is performed at 3 time periods : before start of operation, during cardiopulmonary bypass, and after weaning from cardiopulmonary bypass. | Other | Vascular occlusion test (VOT) |
Primary outcome
Major adverse event
Time frame: up to 1 years after surgery
Major adverse event is defined as cardiac compression, re-sternotomy because of hemodynamic instability, ECMO support, Cr> 2mg/dL, cerebral hemorrhage or infarct and mortality.
2 secondary outcomes
Use of inotropic and vasoactive drugs
Time frame: up to 1 years after surgery
Length of mechanical ventilation time and ICU stay
Time frame: up to 1 years after surgery
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 20 Apr 2017.
- Derived from this study: PubMed 29140967Lee JH, Jang YE, Song IK, Kim EH, Kim HS, Kim JT. Near-Infrared Spectroscopy and Vascular Occlusion Test for Predicting Clinical Outcome in Pediatric Cardiac Patients: A Prospective Observational Study. Pediatr Crit Care Med. 2018 Jan;19(1):32-39. doi: 10.1097/PCC.0000000000001386.
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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 principal investigator
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 vascular occlusion test using Pediatric SomaSensor for INVOS 5100C in people with Congenital Heart Disease, 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 20 Apr 2017. 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?
Major adverse event (time frame: up to 1 years after surgery). 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 NCT02287753, 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 20 Apr 2017.