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CompletedNCT05388396PIMS-TS INTUpdated Feb 14, 2023

PIMS-TS in Intensive Care: Retrospective Cohort Trial

An observational study in Pims-Ts, sponsored by Brno University Hospital. Completed at 1 site in Czechia. Open to participants aged Up to 19 Years. Per ClinicalTrials.gov, last updated 2023-02-14.

Sponsored by Brno University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
180
Ages
Up to 19 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Pims-Ts

Keywords

  • PIMS-TS
  • children
  • child
  • intensive care
  • critical illness
03

In context

Lead sponsor

Brno University Hospital is the lead sponsor of 91 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 19 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Pediatric patients with PIMS-TS admitted to PICU

Inclusion criteria

  • pediatric patients with PIMS-TS
  • PICU admission

Exclusion criteria

Exclusion Criteria:

  • insufficient data
  • patients not admitted to PICU
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
180 participants (actual)
Patient registry
No

Groups and cohorts

  • PIMS-TS patients

    Pediatric patients with PIMS-TS admitted to the PICU in selected time period

    Other: PIMS-TS diagnostic a treatment

Interventions

  • OtherPIMS-TS diagnostic a treatment

    PIMS-TS diagnostic a treatment

06

What researchers measure

Primary outcomes

  1. Initial clinical presentation

    Vital signs

    Time frame: During the first 24 hours after PICU admission

  2. Initial laboratory results

    Time frame: During the first 24 hours after PICU admission

  3. PIMS-TS treatment

    PIMS-TS treatment specification

    Time frame: During the first month after PICU admission

Secondary outcomes

  1. PIMS-TS outcome

    clinical and cardiology outcome after 1 month

    Time frame: after one month from hospital discharge

07

Study locations

1 site
  • Brno University Hospital
    Brno, South Moravian Region 62500, Czechia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05388396
Lead sponsor
Brno University Hospital
Collaborators
University Hospital Motol and 2nd Faculty of medicine, Charles University, Prague, Department of Anaesthesiology and Intensive CareMedicine, The Donaustadt Clinic, Lango Bardenstraße 122, 1220 Vienna, Austria
Responsible party
Petr Štourač, MD (Clinical Professor, Brno University Hospital) — Principal investigator
First posted
May 24, 2022
Start date
Aug 1, 2022
Primary completion
Dec 31, 2022
Completion
Jan 30, 2023
Last update
Feb 14, 2023

Study contacts

Petr Stourac, prof. MD., Ph.D., MBA
study chair · Department of paediatric anaesthesia and intensive care medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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