Complex Congenital Heart DiseaseNCT04810013
Noninvasive Measurement of the Cerebral Autoregulation in Neonates and Infants With Complex Congenital Heart Disease
An observational study of Complex Congenital Heart Disease, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Feasibility of non-invasive cerebral autoregulation measurement at the PICU and impact of changes in oxygen supply Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Complex Congenital Heart Disease
- What is being tested?
- non-invasive measurement of cerebral autoregulation
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2020to 30 Nov 2023
- 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 month
- All sexes
- No healthy volunteers
- Child
Study population: Newborns
Who may be able to join
- term (37-42 weeks gestation) newborns
- pre- or postnatally diagnosed critical congenital heard disease (CHD)
- admitted to the pediatric cardiac intensive care unit at the Children's Hospital of Tübingen
Who cannot join
- birth weight <2 kg
- history of neonatal depression (5-min APGAR<5, cord blood pH<7.0, sepsis, or birth asphyxia)
- perinatal seizures
- evidence of end-organ injury
- preoperative cardiac arrest
- significant preoperative intracerebral hemorrhage such as grade 3 or 4 intraventricular hemorrhage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Noninvasive Measurement of the Cerebral Autoregulation in Neonates and Infants With Complex Congenital Heart Disease After Cardiac Surgery With Cardiopulmonary Bypass at the Pediatric Intensive Care Unit (PICU)
Feasibility of non-invasive cerebral autoregulation measurement at the PICU and impact of changes in oxygen supply
Read the detailed description
Cerebral protection is a major issue in the treatment of neonates and infants with complex congenital heart disease, because most common long-term morbidities of newborn heart surgery are related not to the heart, but instead to the cognitive challenges experienced by this population. Disruption of cerebral autoregulation in the postoperative period may contribute to brain injury in these patients. Blood pressure management, respirator management and red blood cell transfusion management after cardiopulmonary bypass surgery using endpoints such cerebral autoregulation monitoring might provide a method to optimize organ perfusion and improve neurologic outcome from cardiac surgery in the vulnerable postoperative period.
Primary Objectives: Feasibility of non-invasive cerebral autoregulation measurement at the PICU: Identification of the range of mean arterial blood pressure (MAP) with optimal vasoreactivity (MAPOPT), indicating intact cerebral autoregulation.
Secondary Objectives: Impact of decreased oxygen delivery, increased cerebral oxygen extraction, decreased cardiac output, arterial hypotension, severe hypoxemia and/or severe anemia on cerebral autoregulation.
- Conditions
- Complex Congenital Heart Disease
- Being tested
- non-invasive measurement of cerebral autoregulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive measurement of cerebral autoregulationProcedure or surgery
Non-invasive measurement of the cerebral autoregulation in the postoperative period in 80 neonates and infants with complex congenital heart disease undergoing cardiopulmonary bypass surgery. A continuous, moving Pearson's correlation coefficient will be calculated between the arterial pressure and near-infrared spectroscopy signals and displayed continuously during surgery using a laptop computer and the ICM+ software (Cambridge Enterprise).
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of mean arterial blood pressure
Measurement of the range of mean arterial blood pressure (MAP) with optimal vasoreactivity (MAPOPT)
Measured: 4within 8 hours after cardiac surgery at the PICU
Secondary outcomes (6)
Detection of severe brain injury
Detection of cerebral haemorrhage grade III or IV, cystic periventricular leukomalacia, cerebellar haemorrhage, post-haemorrhagic ventricular dilatation or cerebral atrophy) on routinely performed serial cranial ultrasound scans
Measured: before surgery, 12 hours, 48 hours, 72 hours post surgery and before discharge
Neurological outcome measure
Landmarks of development score (Grenzsteine der Entwicklung Score) aus (Monatsschr Kinderheilkd_2013 · 161:898-910_· DOI 10.1007/s00112-012-2751-0 © Springer-Verlag Berlin Heidelberg 2013 R._Michaelis_· R._Berger_· U._Nennstiel-Ratzel_· I._Krägeloh-Mann Validierte und teilvalidierte Grenzsteine der Entwicklung).
The score uses dichotomous questions, that asks for a Yes/No response. The score consists of a total of 16 questions, the more questions answered yes, the better the outcome and vice versa. Minimum value is n=0 yes and n=16 no answers, maximum value is n=16 yes and n=0 no answers.
Measured: at age of 2 years
Influence of changed fractional cerebral oxygen extraction (cFTOE) on cerebral autoregulation
Analysis of the influence of changed fractional cerebral oxygen extraction (cFTOE) on cerebral autoregulation.Association between cFTOE and cerebral autoregulation indices (COx and HVx).
Measured: within 8 hours after cardiac surgery at the PICU
Influence of changed arterial blood pressure on cerebral autoregulation
Analysis of the influence of changed arterial blood pressure on cerebral autoregulation. Association between arterial blood pressure (mmHg) and cerebral autoregulation indices (COx and HVx).
Measured: within 8 hours after cardiac surgery at the PICU
Influence of changed arterial oxygen saturation on cerebral autoregulation
Analysis of the influence of changed arterial oxygen saturation on cerebral autoregulation. Association between arterial SPO2 (%) and cerebral autoregulation indices (COx and HVx).
Measured: within 8 hours after cardiac surgery at the PICU
Influence of changed blood hemoglobin concentration on cerebral autoregulation
- Analysis of the influence of changed blood hemoglobin concentration on cerebral autoregulation. Association between arterial hemoglobin value (g/dL) and cerebral autoregulation indices (COx and HVx).
Measured: within 8 hours after cardiac surgery at the PICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Jun 2020
- Primary completion31 Dec 2022
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Felix Neunhoeffer, Principal investigator, University Children's Hospital Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810013
- Sponsor's protocol ID
- CAR_FN_01
- Status last verified
- May 2022
- First submitted
- 25 Feb 2021
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Measurement of the Cerebral Autoregulation in Neonates and Infants With Complex Congenital Heart Disease After Cardiac Surgery With Cardiopulmonary Bypass at the Pediatric Intensive Care Unit (PICU)
- ClinicalTrials.gov ID
- NCT04810013
- Acronym / sponsor ID
- CAR_FN_01
- Conditions
- Complex Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 22 Mar 2021 (actual)
- 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.
Feasibility of non-invasive cerebral autoregulation measurement at the PICU and impact of changes in oxygen supply
Detailed description
Cerebral protection is a major issue in the treatment of neonates and infants with complex congenital heart disease, because most common long-term morbidities of newborn heart surgery are related not to the heart, but instead to the cognitive challenges experienced by this population. Disruption of cerebral autoregulation in the postoperative period may contribute to brain injury in these patients. Blood pressure management, respirator management and red blood cell transfusion management after cardiopulmonary bypass surgery using endpoints such cerebral autoregulation monitoring might provide a method to optimize organ perfusion and improve neurologic outcome from cardiac surgery in the vulnerable postoperative period.
Primary Objectives: Feasibility of non-invasive cerebral autoregulation measurement at the PICU: Identification of the range of mean arterial blood pressure (MAP) with optimal vasoreactivity (MAPOPT), indicating intact cerebral autoregulation.
Secondary Objectives: Impact of decreased oxygen delivery, increased cerebral oxygen extraction, decreased cardiac output, arterial hypotension, severe hypoxemia and/or severe anemia on cerebral autoregulation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns
Key inclusion criteria (3 listed)
- term (37-42 weeks gestation) newborns
- pre- or postnatally diagnosed critical congenital heard disease (CHD)
- admitted to the pediatric cardiac intensive care unit at the Children's Hospital of Tübingen
Key exclusion criteria (6 listed)
- birth weight <2 kg
- history of neonatal depression (5-min APGAR<5, cord blood pH<7.0, sepsis, or birth asphyxia)
- perinatal seizures
- evidence of end-organ injury
- preoperative cardiac arrest
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 |
|---|---|---|
| non-invasive measurement of cerebral autoregulationNon-invasive measurement of the cerebral autoregulation in the postoperative period in 80 neonates and infants with complex congenital heart disease undergoing cardiopulmonary bypass surgery. A continuous, moving Pearson's correlation coefficient will be calculated between the arterial pressure and near-infrared spectroscopy signals and displayed continuously during surgery using a laptop computer and the ICM+ software (Cambridge Enterprise). | Procedure or surgery | – |
Primary outcome
Range of mean arterial blood pressure
Time frame: 4within 8 hours after cardiac surgery at the PICU
Measurement of the range of mean arterial blood pressure (MAP) with optimal vasoreactivity (MAPOPT)
6 secondary outcomes
Detection of severe brain injury
Time frame: before surgery, 12 hours, 48 hours, 72 hours post surgery and before discharge
Neurological outcome measure
Time frame: at age of 2 years
Influence of changed fractional cerebral oxygen extraction (cFTOE) on cerebral autoregulation
Time frame: within 8 hours after cardiac surgery at the PICU
Influence of changed arterial blood pressure on cerebral autoregulation
Time frame: within 8 hours after cardiac surgery at the PICU
Influence of changed arterial oxygen saturation on cerebral autoregulation
Time frame: within 8 hours after cardiac surgery at the PICU
Influence of changed blood hemoglobin concentration on cerebral autoregulation
Time frame: within 8 hours after cardiac surgery at the PICU
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 21 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Felix Neunhoeffer principal investigator
University Children's Hospital Tübingen
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 Complex Congenital Heart Disease, run by University Hospital Tuebingen at 1 site in Germany.
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 21 Dec 2023. 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 Germany. 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?
Range of mean arterial blood pressure (time frame: 4within 8 hours after cardiac surgery at the PICU). 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 21 Dec 2023.