PIMS-TS in Intensive Care: Retrospective Cohort Trial

Completed

• Conditions: Pims-Ts
• Interventions: Other: PIMS-TS diagnostic a treatment

• Registration Number: NCT05388396
• Lead Sponsor: Brno University Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-24
• Study Start: 2022-08-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• pediatric patients with PIMS-TS
• PICU admission

Exclusion Criteria

• insufficient data
• patients not admitted to PICU

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PIMS-TS patients	PIMS-TS diagnostic a treatment	Pediatric patients with PIMS-TS admitted to the PICU in selected time period

Primary Outcome Measures

Name	Time	Method
Initial laboratory results	During the first 24 hours after PICU admission
Initial clinical presentation	During the first 24 hours after PICU admission	Vital signs
PIMS-TS treatment	During the first month after PICU admission	PIMS-TS treatment specification

Secondary Outcome Measures

Name	Time	Method
PIMS-TS outcome	after one month from hospital discharge	clinical and cardiology outcome after 1 month

Trial Locations

Locations (1)

Brno University Hospital; 🇨🇿 Brno, South Moravian Region, Czechia