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

• Sponsor: Vincenzo Cannizzaro (Other)
• Overall Status: Completed
• CT.gov ID: NCT03320967
• Collaborator: (none)
• Enrollment: 170
• Location: 1
• Actual Duration (Months): 18.8
• Patients Per Site Per Month: 9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Hypotension in Critically Ill Neonatal and Pediatric Patients	Diagnostic Test: Copeptin in plasma

Study Design

• Study Type: Observational
• Actual Enrollment: 170 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: COpeptin in Critically Ill Paediatric and Neonatal Intensive Care Patients and Its Association With Arterial Hypotension. A Single-centre Prospective Observational Study.
• Actual Study Start Date: Dec 4, 2017
• Actual Primary Completion Date: Jun 30, 2019
• Actual Study Completion Date: Jun 30, 2019

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. Length of respiratory support [Up to 168 hours.]

   Association of copeptin values with length of respiratory Support.

3. Length and dose of catecholamine therapy [Up to 168 hours.]

   Association of copeptin values with length and dose of catecholamine therapy.

4. Rate of death [Up to 168 hours.]

   Rate of death at 28 days.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Children's Hospital Zurich	Zürich		Switzerland	8032

Sponsors and Collaborators

• Vincenzo Cannizzaro

Investigators

• Study Director: Vinzenco Cannizzaro, MD, PhD, University Children's Hospital, Zurich

Study Documents (Full-Text)

• Study Protocol - Aug 17, 2017

More Information

Publications

None provided.

• Responsible Party: Vincenzo Cannizzaro, Vice-head Department of Pediatric Intensive Care and Neonatology, University Children's Hospital, Zurich
• ClinicalTrials.gov Identifier: NCT03320967
• Other Study ID Numbers: KISPI-COPNIC
• First Posted: Oct 25, 2017
• Last Update Posted: Jul 5, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypotension; Critical Illness; Arginine Vasopressin

Study Results

No Results Posted as of Jul 5, 2019