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OpenTrials
Completed

NCT Number: NCT05388396

PIMS-TS in Intensive Care: Retrospective Cohort Trial

Pediatric Multisystem Inflammatory Syndrome Temporally associated with SARS-CoV-2, (PMIS-TS) represents the new unit, partially imitating the previously described Kawasaki disease. Due to variable and frequently incomplete clinical presentation together with variable disease severity, the real incidence in pediatric population remains unclear. Currently, PIMS-TS is defined by persistent fever, elevation of inflammatory markers, organ dysfunction (cardiac, central nervous system, respiratory, coagulation, renal, gastrointestinal), skin lesions (exanthematous), and absence of other possible etiology.

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Key information

Age range

Up to 19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Brno University Hospital

Brno, South Moravian, 62500, Czechia

About this study

During the world COVID-19 pandemic (2020-2022), pediatric patients with PIMS-TS represented a significant part of pediatric intensive care unit (PICU) load. The initial clinical presentation of patients with PIMS-TS could vary significantly, and also due to progressively evolving recommendations, the diagnostic a therapy could vary regionally and over the time too. The aim of this retrospective cohort trial was to describe the initial clinical presentation, diagnostics, therapy and clinical outcome of pediatric patients admitted during 2020-2022 to the one of the 3 university hospital PICUs.

Who can participate

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

Inclusion criteria

  • pediatric patients with PIMS-TS
  • PICU admission

Exclusion criteria

  • insufficient data
  • patients not admitted to PICU

Treatment and study plan

PIMS-TS diagnostic a treatment

Other

PIMS-TS diagnostic a treatment

Primary outcomes

  1. Initial clinical presentation

    Time frame: During the first 24 hours after PICU admission

    Vital signs

  2. Initial laboratory results

    Time frame: During the first 24 hours after PICU admission

  3. PIMS-TS treatment

    Time frame: During the first month after PICU admission

    PIMS-TS treatment specification

Secondary outcomes

  1. PIMS-TS outcome

    Time frame: after one month from hospital discharge

    clinical and cardiology outcome after 1 month

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Collaborators

  • Department of Anaesthesiology and Intensive CareMedicine, The Donaustadt Clinic, Lango Bardenstraße 122, 1220 Vienna, Austria
  • University Hospital, Motol

Registry information

Official study title

Pediatric Inflammatory Multisystem Syndrome (PIMS-TS) in Pediatric Intensive Care: Retrospective Cohort Trial

Acronym: PIMS-TS INT

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 24, 2022
Registry last updated
Feb 14, 2023

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.

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