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

July 3, 2019 updated by: Vincenzo Cannizzaro

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8032
        • University Children's Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 168 hours.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vincenzo Cannizzaro

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 4, 2017

Primary Completion (ACTUAL)

June 30, 2019

Study Completion (ACTUAL)

June 30, 2019

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

October 20, 2017

First Posted (ACTUAL)

October 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KISPI-COPNIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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