Completed

NCT Number: NCT03320967

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arterial Hypotension in Critically Ill Neonatal and Pediatric Patients

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Zurich

Zurich, 8032, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Copeptin in plasma

Diagnostic Test

Copeptin will be measured in EDTA-Plasma. Samples will be stored for batch analyses later.

Primary outcomes

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.

Secondary outcomes

Length of stay on the intensive care unit

Time frame: Up to 168 hours.

Association of copeptin values with length of stay on the intensive care unit.
Length of respiratory support

Time frame: Up to 168 hours.

Association of copeptin values with length of respiratory Support.
Length and dose of catecholamine therapy

Time frame: Up to 168 hours.

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

Time frame: Up to 168 hours.

Rate of death at 28 days.

Sponsors and collaborators

Lead sponsor

Vincenzo Cannizzaro

Other

Registry information

Official study title

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

Acronym: COPNIC

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Oct 25, 2017
Registry last updated: Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.