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

NCT ID: NCT03320967

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-04

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Arterial Hypotension in Critically Ill Neonatal and Pediatric Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Copeptin in plasma

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vincenzo Cannizzaro

OTHER

Sponsor Role lead

Responsible Party

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Vincenzo Cannizzaro

Vice-head Department of Pediatric Intensive Care and Neonatology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Vinzenco Cannizzaro, MD, PhD

Role: STUDY_DIRECTOR

University Children's Hospital, Zurich

Locations

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University Children's Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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KISPI-COPNIC

Identifier Type: -

Identifier Source: org_study_id

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