PIMS-TS in Intensive Care: Retrospective Cohort Trial | NCT05388396

Studies
PIMS-TS in Intensive Care: Retrospective Cohort Trial

NCT05388396

Sponsor

Brno University Hospital

Status

Completed

Last Update Posted

Feb 14, 2023Actual

Enrollment

180Actual

Phase

Not provided

Conditions

Pims-Ts

Interventions

PIMS-TS diagnostic a treatment

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2022Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Jan 30, 2023Actual

First Submitted Date

May 18, 2022

First Submission Date that Met QC Criteria

May 23, 2022

First Posted Date

May 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2023

Last Update Posted Date

Feb 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Petr Štourač, MD, Clinical Professor, Brno University HospitalPrincipal Investigator

Lead Sponsor

Brno University HospitalOTHER

Collaborators

Name	Class
University Hospital, Motol	OTHER
Department of Anaesthesiology and Intensive CareMedicine, The Donaustadt Clinic, Lango Bardenstraße 122, 1220 Vienna, Austria	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PIMS-TS patients		Pediatric patients with PIMS-TS admitted to the PICU in selected time period	Other: PIMS-TS diagnostic a treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PIMS-TS diagnostic a treatment	Other	PIMS-TS diagnostic a treatment	PIMS-TS patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pediatric patients with PIMS-TS
PICU admission

Exclusion Criteria:

insufficient data
patients not admitted to PICU

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

Pediatric patients with PIMS-TS admitted to PICU

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Petr Stourac, prof. MD., Ph.D., MBA	Department of paediatric anaesthesia and intensive care medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brno University Hospital		Brno	South Moravian	62500	Czechia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C000705967	pediatric multisystem inflammatory disease, COVID-19 related
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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