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

Study Overview
=================
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.

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

Conditions
-----------------
Arterial Hypotension in Critically Ill Neonatal and Pediatric Patients

Intervention / Treatment
-----------------
* Diagnostic Test: Copeptin in plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Copeptin in plasma|Copeptin will be measured in EDTA-Plasma. Samples will be stored for batch analyses later.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Length of respiratory support | Association of copeptin values with length of respiratory Support. | Up to 168 hours. | 
| Length and dose of catecholamine therapy | Association of copeptin values with length and dose of catecholamine therapy. | Up to 168 hours. | 
| Rate of death | Rate of death at 28 days. | Up to 168 hours. |