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

NCT03320967 | Completed

• 1 other identifier: KISPI-COPNIC
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Hypotension in Critically Ill Neonatal and Pediatric Patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Length of stay on the intensive care unit

  Up to 168 hours.

• Length of respiratory support

  Up to 168 hours.

• Length and dose of catecholamine therapy

  Up to 168 hours.

• Rate of death

  Up to 168 hours.

Interventions

Copeptin in plasma DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

This is a study designed to explore Copeptin values in all kinds of critically ill paediatric patients. Patients with normal blood pressures will allow calculating Copeptin reference values for the ones requiring cardiovascular support. Therefore, all patients, irrespective of their medical condition (e.g. medical or surgical, mildly or severely affected) and their age (neonates to adolescents) admitted to the Intensive Care Unit of the University's Children Hospital Zurich will be eligible, as long as they fulfil the mentioned inclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vincenzo Cannizzaro: lead

Study Sites (1)

University Children's Hospital Zurich

Zurich, 8032, Switzerland

Location

Study Officials

• Vinzenco Cannizzaro, MD, PhD

  University Children's Hospital, Zurich

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice-head Department of Pediatric Intensive Care and Neonatology

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 25, 2017
• Study Start: December 4, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)