Arterial Hypotension in Critically Ill Neonatal and Pediatric PatientsCOPNICNCT03320967
Copeptin and Arterial Hypotension in Critically Ill Paediatric and Neonatal Intensive Care Patients
An observational study of Arterial Hypotension in Critically Ill Neonatal and Pediatric Patients, run by Vincenzo Cannizzaro at 1 site in Switzerland.
Trial summary
Blood copeptin will be measured during the routine treatment of neonates, children and adolescents on the Intensive Care Unit of the University Children's Hospital Zurich at different time points (admission, 12, 24, 48, 96, 168 hours after admission). Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Arterial Hypotension in Critically Ill Neonatal and Pediatric Patients
- What is being tested?
- Copeptin in plasma
- How many people
- 170 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Dec 2017to 30 Jun 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: This is a study designed to explore Copeptin values in all kinds of critically ill paediatric patients. Patients with normal blood pressures will allow calculating Copeptin reference values for the ones requiring cardiovascular support. Therefore, all patients, irrespective of their medical condition (e.g. medical or surgical, mildly or severely affected) and their age (neonates to adolescents) admitted to the Intensive Care Unit of the University's Children Hospital Zurich will be eligible, as long as they fulfil the mentioned inclusion criteria.
Who may be able to join
- Age: first day of life until 18th birthday.
- Ability of the care taker or the adolescent (if≥14 years of age) to understand verbal and written instructions and informed consent in German.
Who cannot join
- Care taker or adolescent (if ≥14 years of age) unwilling to give written informed consent.
- Care taker or adolescent (if ≥14 years of age) not understanding German and without a family member able to translate.
- Adolescent (if ≥14 years of age) unwilling to give written informed consent following sedation < 24 hours.
- Care takers of long-term sedated (>24 hours) adolescents (if ≥14 years of age) unwilling to give written informed consent or not present within 24 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COpeptin in Critically Ill Paediatric and Neonatal Intensive Care Patients and Its Association With Arterial Hypotension. A Single-centre Prospective Observational Study.
Blood copeptin will be measured during the routine treatment of neonates, children and adolescents on the Intensive Care Unit of the University Children's Hospital Zurich at different time points (admission, 12, 24, 48, 96, 168 hours after admission). These values will be primarily analysed for their variability and their association with arterial hypotension. Blood samples will be drawn together with otherwise medically indicated blood withdrawals to avoid extra harm. Further, copeptin values will be compared to clinical and vital parameters, all of them open-label available during clinical routine. Copeptin's predictive value for patients' outcome will be analysed as secondary outcome.
- Being tested
- Copeptin in plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copeptin in plasmaDiagnostic test
Copeptin will be measured in EDTA-Plasma. Samples will be stored for batch analyses later.
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood copeptin in arterial normo- and hypotension
Average change of blood copeptin in patients with both arterial normo- and hypotension and different pathologies.
Measured: Up to 168 hours.
Secondary outcomes (4)
Length of stay on the intensive care unit
Association of copeptin values with length of stay on the intensive care unit.
Measured: Up to 168 hours.
Length of respiratory support
Association of copeptin values with length of respiratory Support.
Measured: Up to 168 hours.
Length and dose of catecholamine therapy
Association of copeptin values with length and dose of catecholamine therapy.
Measured: Up to 168 hours.
Rate of death
Rate of death at 28 days.
Measured: Up to 168 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start4 Dec 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Hypotension in Critically Ill Neonatal and Pediatric PatientsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vincenzo Cannizzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vincenzo Cannizzaro, University Children's Hospital, Zurich
- Investigators
- Vinzenco Cannizzaro, MD, PhD, Study director, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320967
- Sponsor's protocol ID
- KISPI-COPNIC
- Acronym
- COPNIC
- Status last verified
- Jul 2019
- First submitted
- 4 Oct 2017
- Last updated
- 5 Jul 2019
- 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 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COpeptin in Critically Ill Paediatric and Neonatal Intensive Care Patients and Its Association With Arterial Hypotension. A Single-centre Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT03320967
- Acronym / sponsor ID
- COPNIC / KISPI-COPNIC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Vincenzo CannizzaroUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 25 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.
Blood copeptin will be measured during the routine treatment of neonates, children and adolescents on the Intensive Care Unit of the University Children's Hospital Zurich at different time points (admission, 12, 24, 48, 96, 168 hours after admission). These values will be primarily analysed for their variability and their association with arterial hypotension. Blood samples will be drawn together with otherwise medically indicated blood withdrawals to avoid extra harm. Further, copeptin values will be compared to clinical and vital parameters, all of them open-label available during clinical routine. Copeptin's predictive value for patients' outcome will be analysed as secondary outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This is a study designed to explore Copeptin values in all kinds of critically ill paediatric patients. Patients with normal blood pressures will allow calculating Copeptin reference values for the ones requiring cardiovascular support. Therefore, all patients, irrespective of their medical condition (e.g. medical or surgical, mildly or severely affected) and their age (neonates to adolescents) admitted to the Intensive Care Unit of the University's Children Hospital Zurich will be eligible, as long as they fulfil the mentioned inclusion criteria.
Key inclusion criteria (2 listed)
- Age: first day of life until 18th birthday.
- Ability of the care taker or the adolescent (if≥14 years of age) to understand verbal and written instructions and informed consent in German.
Key exclusion criteria (4 listed)
- Care taker or adolescent (if ≥14 years of age) unwilling to give written informed consent.
- Care taker or adolescent (if ≥14 years of age) not understanding German and without a family member able to translate.
- Adolescent (if ≥14 years of age) unwilling to give written informed consent following sedation < 24 hours.
- Care takers of long-term sedated (>24 hours) adolescents (if ≥14 years of age) unwilling to give written informed consent or not present within 24 hours.
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 |
|---|---|---|
| Copeptin in plasmaCopeptin will be measured in EDTA-Plasma. Samples will be stored for batch analyses later. | Diagnostic test | – |
Primary outcome
Blood copeptin in arterial normo- and hypotension
Time frame: Up to 168 hours.
Average change of blood copeptin in patients with both arterial normo- and hypotension and different pathologies.
4 secondary outcomes
Length of stay on the intensive care unit
Time frame: Up to 168 hours.
Length of respiratory support
Time frame: Up to 168 hours.
Length and dose of catecholamine therapy
Time frame: Up to 168 hours.
Rate of death
Time frame: Up to 168 hours.
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 Jul 2019.
- Individual participant dataSharing planned: No
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.
Vinzenco Cannizzaro, MD, PhD study director
University Children's Hospital, Zurich
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 Arterial Hypotension in Critically Ill Neonatal and Pediatric Patients, run by Vincenzo Cannizzaro at 1 site in Switzerland.
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 2 inclusion and 4 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 Jul 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 Switzerland. 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?
Blood copeptin in arterial normo- and hypotension (time frame: Up to 168 hours.). 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 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.