Congenital Heart DefectNCT02884973
Prospective Evaluation of Changes in Tissue Oxygen Saturation in Brain and Kidney in Children Admitted to Intensive Care in the Postoperative Period of Cardiac Surgery
An observational study of Congenital Heart Defect, run by University Hospital, Strasbourg, France.
Trial summary
It is estimated that the incidence of congenital heart disease varies between 0.5 and 1% of live births, 5,000 new cases per year currently in France These are serious diseases that can be life-threatening to more or less short term. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Congenital Heart Defect
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jun 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 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged under 5 years who underwent cardiac surgery (palliative or curative) and postoperative hospital period in pediatric resuscitation
Who may be able to join
- Children under 5 years
- Allowed in pediatric intensive care unit
- Having received heart surgery for management of congenital heart disease
Who cannot join
- Patients aged over 5 years
- Violations preexisting brain to the intervention (brain malformation)
- Patients with congenital heart disease and admitted to intensive care for reasons other than the surgical treatment of heart disease
Trial locations and contacts
No sites are listed yet.
About this study
It is estimated that the incidence of congenital heart disease varies between 0.5 and 1% of live births, 5,000 new cases per year currently in France These are serious diseases that can be life-threatening to more or less short term.
The advances in surgical techniques in recent years has improved the prognosis of these patients in the first months of life.
Read more
The success of surgery is, among other things, conditioned by a support per complex operation, involving a multimodal intensive monitoring, and respiratory and hemodynamic support techniques.
These elements of surveillance, NIRS (Near-infrared spectroscopy) allows measurement of non-invasive tissue saturation (rSO2) in cerebral and renal oxygen.
The fundamental principle of NIRS based on an estimate of the percentage proportion of cerebral oxy-hemoglobin.
A light source is emitted by NIRS and through body tissues to the brain where the light will be absorbed and refracted depending on the tissue composition in oxy-hemoglobin.
Refracted light will be analyzed by NIRS which in turn using software will help to determine a percentage of oxyhemoglobin.
Normal values of cerebral NIRS are between 50 and 80%.NIRS can be used according to this principle to estimate cerebral tissue oxygenation but also for other tissues such as the kidney.
More than the figure, those are changes NIRS compared to a baseline that will alert us to the conditions of tissue oxygenation and allow us to identify hypoxia times.
Changes in the value of the NIRS depends on 3 criteria: the tissue blood flow, the percentage of oxyhemoglobin and deoxyhemoglobin percentage.
- Conditions
- Congenital Heart Defect
- Keywords
- congenital heart, NIRS
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen saturation in brain and kidney tissue
Measured: 1 hour after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884973
- Sponsor's protocol ID
- 6156
- Status last verified
- Jun 2016
- First submitted
- 16 Jun 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Changes in Tissue Oxygen Saturation in Brain and Kidney in Children Admitted to Intensive Care in the Postoperative Period of Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02884973
- Acronym / sponsor ID
- 6156
- Conditions
- Congenital Heart Defect
- Keywords
- congenital heart, NIRS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 31 Aug 2016 (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.
It is estimated that the incidence of congenital heart disease varies between 0.5 and 1% of live births, 5,000 new cases per year currently in France These are serious diseases that can be life-threatening to more or less short term.
The advances in surgical techniques in recent years has improved the prognosis of these patients in the first months of life.
The success of surgery is, among other things, conditioned by a support per complex operation, involving a multimodal intensive monitoring, and respiratory and hemodynamic support techniques.
These elements of surveillance, NIRS (Near-infrared spectroscopy) allows measurement of non-invasive tissue saturation (rSO2) in cerebral and renal oxygen.
The fundamental principle of NIRS based on an estimate of the percentage proportion of cerebral oxy-hemoglobin.
A light source is emitted by NIRS and through body tissues to the brain where the light will be absorbed and refracted depending on the tissue composition in oxy-hemoglobin.
Refracted light will be analyzed by NIRS which in turn using software will help to determine a percentage of oxyhemoglobin.
Normal values of cerebral NIRS are between 50 and 80%.NIRS can be used according to this principle to estimate cerebral tissue oxygenation but also for other tissues such as the kidney.
More than the figure, those are changes NIRS compared to a baseline that will alert us to the conditions of tissue oxygenation and allow us to identify hypoxia times.
Changes in the value of the NIRS depends on 3 criteria: the tissue blood flow, the percentage of oxyhemoglobin and deoxyhemoglobin percentage.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged under 5 years who underwent cardiac surgery (palliative or curative) and postoperative hospital period in pediatric resuscitation
Key inclusion criteria (3 listed)
- Children under 5 years
- Allowed in pediatric intensive care unit
- Having received heart surgery for management of congenital heart disease
Key exclusion criteria (3 listed)
- Patients aged over 5 years
- Violations preexisting brain to the intervention (brain malformation)
- Patients with congenital heart disease and admitted to intensive care for reasons other than the surgical treatment of heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
oxygen saturation in brain and kidney tissue
Time frame: 1 hour after cardiac surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Individual participant dataSharing planned: No
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A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Defect, run by University Hospital, Strasbourg, France.
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 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: status not confirmed, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Sophie Guilbert, MD (33 (0)3 88 12 73 20, anne-sophie.guilbert@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygen saturation in brain and kidney tissue (time frame: 1 hour after cardiac surgery). 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 31 Aug 2016.