Copeptin and Arterial Hypotension in Critically Ill Paediatric and Neonatal Intensive Care Patients

Arterial Hypotension in Critically Ill Neonatal and Pediatric Patients Clinical Trial

— COPNIC  

Official title:

COpeptin in Critically Ill Paediatric and Neonatal Intensive Care Patients and Its Association With Arterial Hypotension. A Single-centre Prospective Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320967
• Other study ID #: KISPI-COPNIC
• Status: Completed
• Start date: December 4, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2019
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Arterial Hypotension in Critically Ill Neonatal and Pediatric Patients
• Critical Illness
• Hypotension

Intervention

Diagnostic Test:
• Copeptin in plasma
Copeptin will be measured in EDTA-Plasma. Samples will be stored for batch analyses later.

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Vincenzo Cannizzaro

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood copeptin in arterial normo- and hypotension	Average change of blood copeptin in patients with both arterial normo- and hypotension and different pathologies.	Up to 168 hours.
Secondary	Length of stay on the intensive care unit	Association of copeptin values with length of stay on the intensive care unit.	Up to 168 hours.
Secondary	Length of respiratory support	Association of copeptin values with length of respiratory Support.	Up to 168 hours.
Secondary	Length and dose of catecholamine therapy	Association of copeptin values with length and dose of catecholamine therapy.	Up to 168 hours.
Secondary	Rate of death	Rate of death at 28 days.	Up to 168 hours.