PIMS-TS in Intensive Care: Retrospective Cohort Trial (PIMS-TS INT)

February 10, 2023 updated by: Petr Štourač, MD, Brno University Hospital

Pediatric Inflammatory Multisystem Syndrome (PIMS-TS) in Pediatric 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

180

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

  • Czechia
    • South Moravian Region
      • Brno, South Moravian Region, Czechia, 62500
        • Brno University Hospital

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 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients with PIMS-TS admitted to PICU

Description

Inclusion Criteria:

  • pediatric patients with PIMS-TS
  • PICU admission

Exclusion Criteria:

  • insufficient data
  • patients not admitted to PICU

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PIMS-TS patients
Pediatric patients with PIMS-TS admitted to the PICU in selected time period
Other: PIMS-TS diagnostic a treatment
PIMS-TS diagnostic a treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial clinical presentation
Time Frame: During the first 24 hours after PICU admission
Vital signs
During the first 24 hours after PICU admission
Initial laboratory results
Time Frame: During the first 24 hours after PICU admission
During the first 24 hours after PICU admission
PIMS-TS treatment
Time Frame: During the first month after PICU admission
PIMS-TS treatment specification
During the first month after PICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PIMS-TS outcome
Time Frame: after one month from hospital discharge
clinical and cardiology outcome after 1 month
after one month from hospital discharge

Collaborators and Investigators

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

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

August 1, 2022

Primary Completion (ACTUAL)

December 31, 2022

Study Completion (ACTUAL)

January 30, 2023

Study Registration Dates

First Submitted

May 18, 2022

First Submitted That Met QC Criteria

May 23, 2022

First Posted (ACTUAL)

May 24, 2022

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PIMS-TS INT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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