Congenital Heart DiseaseNCT03316508
Copeptin- Relevance as a Perioperative Marker in Pediatric Cardiac Surgery
An observational study of Congenital Heart Disease, run by Claudia Herbst at 1 site in Austria.
Trial summary
This study evaluates the relevance of Copeptin in children with congenital heart disease undergoing cardiac surgery with the need of cardiopulmonary bypass. Three blood samples are taken of each patient. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 81 participants
- Where
- 1 siteAustria
- Study dates
- 14 Jun 2017to 10 Aug 2019
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of 81 patients (neonates, infants, children) with congenital heart disease and the need of cardiac surgery with a heart-lung machine. Parental consent after pre-operative consultation and informing about the study is required.
Who may be able to join
- ≤6 years of age
- CHD
- need of HLM for surgery
- Informed consent of parents
- not participating in other studies
Who cannot join
- Preoperative ventilatory support
- Preoperative circulatory support (ECMO, VAD)
- Diabetes insipidus
- Preoperative CPR
- Preoperative shock
- Preoperative sepsis
- Preoperative vasopressin application
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the relevance of Copeptin in children with congenital heart disease undergoing cardiac surgery with the need of cardiopulmonary bypass. Three blood samples are taken of each patient. The first and second sample are collected in the operation room before and after the procedure and the third sample on the first postoperative day at the intensive care unit.
Read the detailed description
Objective:
Vasopressin is a hormone secreted by the posterior pituitary gland. Its main functions are constriction of blood vessels and reabsorption of water and thereby regulating water balance and hemodynamics of the body. Copeptin is a cleavage product in the synthesis of vasopressin and is released in equimolar amounts. Its stability makes it easier to determine the amount of vasopressin. It is known, that the use of a heart-lung machine in cardiac procedures has effects on the water balance of the body and may affect the vasopressin secretion.
The aim of this prospective clinical trial is, to figure out if copeptin would be suitable for perioperative risk evaluation in neonates and children with congenital heart disease after surgery with the use of a heart-lung machine.
Hypotheses:
The primary outcome endpoint of this study is the change in copeptin concentration perioperatively in patients with congenital heart disease, with the use of heart-lung machine.
Secondary outcome endpoints are correlations between copeptin concentration and complexity of the procedure (based on the aristotle basic score), clinical status and the perfusion times of the heart-lung machine.
- Conditions
- Congenital Heart Disease
- Keywords
- copeptin, pediatric cardiac surgery, heart lung machine
- Medical subject headings
- Heart Defects, Congenital, Diabetes Insipidus
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Copeptin concentrations
Change of Copeptin concentrations between the baseline and first postoperative measurement
Measured: baseline and up to one day
Secondary outcomes (4)
Intubation
Duration of intubation time
Measured: up to one day
Cardiopulmonary bypass
Total time of cardiopulmonary bypass and aortic cross clamp time.
Measured: up to one day
ICU stay
Length of ICU stay
Measured: up to one day
Complexity of procedures
The surgical complexity of the procedures undergone by the patients will be shown by using a scoring system developed for this purpose named Aristotle Score
Measured: up to one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start14 Jun 2017
- Primary completion1 Oct 2018
- Study completion10 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claudia Herbst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Claudia Herbst, Medical University of Vienna
- Investigators
- Claudia R Herbst, MD, Principal investigator, Medical University Vienna Department for Cardiac Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316508
- Sponsor's protocol ID
- CHS1706001
- Status last verified
- Sep 2019
- First submitted
- 2 Oct 2017
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin- Relevance as a Perioperative Marker in Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03316508
- Acronym / sponsor ID
- CHS1706001
- Conditions
- Congenital Heart Disease
- Keywords
- copeptin, pediatric cardiac surgery, heart lung machine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Claudia HerbstUniversity, hospital or other
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 10 Aug 2019 (actual)
- First posted
- 20 Oct 2017 (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.
This study evaluates the relevance of Copeptin in children with congenital heart disease undergoing cardiac surgery with the need of cardiopulmonary bypass. Three blood samples are taken of each patient. The first and second sample are collected in the operation room before and after the procedure and the third sample on the first postoperative day at the intensive care unit.
Detailed description
Objective:
Vasopressin is a hormone secreted by the posterior pituitary gland. Its main functions are constriction of blood vessels and reabsorption of water and thereby regulating water balance and hemodynamics of the body. Copeptin is a cleavage product in the synthesis of vasopressin and is released in equimolar amounts. Its stability makes it easier to determine the amount of vasopressin. It is known, that the use of a heart-lung machine in cardiac procedures has effects on the water balance of the body and may affect the vasopressin secretion.
The aim of this prospective clinical trial is, to figure out if copeptin would be suitable for perioperative risk evaluation in neonates and children with congenital heart disease after surgery with the use of a heart-lung machine.
Hypotheses:
The primary outcome endpoint of this study is the change in copeptin concentration perioperatively in patients with congenital heart disease, with the use of heart-lung machine.
Secondary outcome endpoints are correlations between copeptin concentration and complexity of the procedure (based on the aristotle basic score), clinical status and the perfusion times of the heart-lung machine.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of 81 patients (neonates, infants, children) with congenital heart disease and the need of cardiac surgery with a heart-lung machine. Parental consent after pre-operative consultation and informing about the study is required.
Key inclusion criteria (5 listed)
- ≤6 years of age
- CHD
- need of HLM for surgery
- Informed consent of parents
- not participating in other studies
Key exclusion criteria (7 listed)
- Preoperative ventilatory support
- Preoperative circulatory support (ECMO, VAD)
- Diabetes insipidus
- Preoperative CPR
- Preoperative shock
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
Change of Copeptin concentrations
Time frame: baseline and up to one day
Change of Copeptin concentrations between the baseline and first postoperative measurement
4 secondary outcomes
Intubation
Time frame: up to one day
Cardiopulmonary bypass
Time frame: up to one day
ICU stay
Time frame: up to one day
Complexity of procedures
Time frame: up to one day
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 11 Sep 2019.
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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.
Claudia R Herbst, MD principal investigator
Medical University Vienna Department for Cardiac Surgery
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 Congenital Heart Disease, run by Claudia Herbst at 1 site in Austria.
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 5 inclusion and 7 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 11 Sep 2019. 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 Austria. 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 of Copeptin concentrations (time frame: baseline and up to one day). 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 11 Sep 2019.