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

Completed

• Conditions: Arterial Hypotension in Critically Ill Neonatal and Pediatric Patients

• Registration Number: NCT03320967
• Lead Sponsor: Vincenzo Cannizzaro

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-25
• Study Start: 2017-12-04
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood copeptin in arterial normo- and hypotension	Up to 168 hours.	Average change of blood copeptin in patients with both arterial normo- and hypotension and different pathologies.

Secondary Outcome Measures

Name	Time	Method
Length of stay on the intensive care unit	Up to 168 hours.	Association of copeptin values with length of stay on the intensive care unit.
Length of respiratory support	Up to 168 hours.	Association of copeptin values with length of respiratory Support.
Length and dose of catecholamine therapy	Up to 168 hours.	Association of copeptin values with length and dose of catecholamine therapy.
Rate of death	Up to 168 hours.	Rate of death at 28 days.

Trial Locations

Locations (1)

University Children's Hospital Zurich; 🇨🇭 Zürich, Switzerland