Pims-TsPIMS-TS INTNCT05388396
PIMS-TS in Intensive Care: Retrospective Cohort Trial
An observational study of Pims-Ts, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Pediatric Multisystem Inflammatory Syndrome Temporally associated with SARS-CoV-2, (PMIS-TS) represents the new unit, partially imitating the previously described Kawasaki disease. Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Pims-Ts
- What is being tested?
- PIMS-TS diagnostic a treatment
- How many people
- 180 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Aug 2022to 30 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 19 years
- All sexes
- Child, Adult
Study population: Pediatric patients with PIMS-TS admitted to PICU
Who may be able to join
- pediatric patients with PIMS-TS
- PICU admission
Who cannot join
- insufficient data
- patients not admitted to PICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Pims-Ts
- Being tested
- PIMS-TS diagnostic a treatment
- Keywords
- PIMS-TS, children, child, intensive care, critical illness
- Medical subject headings
- pediatric multisystem inflammatory disease, COVID-19 related, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIMS-TS diagnostic a treatmentOther
PIMS-TS diagnostic a treatment
| Study group | Role | What they receive |
|---|---|---|
| PIMS-TS patients | Pediatric patients with PIMS-TS admitted to the PICU in selected time period Receives: Other: PIMS-TS diagnostic a treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial clinical presentation
Vital signs
Measured: During the first 24 hours after PICU admission
Initial laboratory results
Measured: During the first 24 hours after PICU admission
PIMS-TS treatment
PIMS-TS treatment specification
Measured: During the first month after PICU admission
Secondary outcomes (1)
PIMS-TS outcome
clinical and cardiology outcome after 1 month
Measured: after one month from hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Aug 2022
- Primary completion31 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pims-TsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Motol, Department of Anaesthesiology and Intensive CareMedicine, The Donaustadt Clinic, Lango Bardenstraße 122, 1220 Vienna, Austria
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Stourac, prof. MD., Ph.D., MBA, Study chair, Department of paediatric anaesthesia and intensive care medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388396
- Sponsor's protocol ID
- PIMS-TS INT
- Acronym
- PIMS-TS INT
- Status last verified
- Feb 2023
- First submitted
- 18 May 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Inflammatory Multisystem Syndrome (PIMS-TS) in Pediatric Intensive Care: Retrospective Cohort Trial
- ClinicalTrials.gov ID
- NCT05388396
- Acronym / sponsor ID
- PIMS-TS INT / PIMS-TS INT
- Conditions
- Pims-Ts
- Keywords
- PIMS-TS, children, child, intensive care, critical illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Motol, Department of Anaesthesiology and Intensive CareMedicine, The Donaustadt Clinic, Lango Bardenstraße 122, 1220 Vienna, Austria
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PIMS-TS patients | – | Other: PIMS-TS diagnostic a treatmentPediatric patients with PIMS-TS admitted to the PICU in selected time period |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Pediatric patients with PIMS-TS admitted to PICU
Key inclusion criteria (2 listed)
- pediatric patients with PIMS-TS
- PICU admission
Key exclusion criteria (2 listed)
- insufficient data
- patients not admitted to PICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIMS-TS diagnostic a treatmentPIMS-TS diagnostic a treatment | Other | PIMS-TS patients |
Primary outcome
Initial clinical presentation
Time frame: During the first 24 hours after PICU admission
Vital signs
Initial laboratory results
Time frame: During the first 24 hours after PICU admission
PIMS-TS treatment
Time frame: During the first month after PICU admission
PIMS-TS treatment specification
1 secondary outcome
PIMS-TS outcome
Time frame: after one month from hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Pims-Ts
RecruitingObservational study
Genetic Basis of SARS-CoV-2 Infection-Associated Multisystem Inflammatory Syndrome in Children (MIS-C)
MIS-C Associated With COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Stourac, prof. MD., Ph.D., MBA study chair
Department of paediatric anaesthesia and intensive care medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pims-Ts, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial clinical presentation (time frame: During the first 24 hours after PICU admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.