ShockPOL-CICUNCT06371677
Polish Nationwide Register of Hospitalized Patients in Cardiac Intensive Care Units
An observational study of Shock and Death, run by Medical University of Warsaw.
Trial summary
Cardiac Intensive Care Units (CICUs) provide care for a diverse patient population. Understanding the clinical characteristics, analysis of treatment modalities, and prognosis of patients hospitalized in the CICU are important to improve cardiovascular care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shock, Death, Cardiac Intensive Care Unit
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 31 Mar 2025
- How long will I take part?
- 3 Months
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All consecutive patients hospitalized at Polish CICUs.
All consecutive patients hospitalized at Polish CICUs.
Trial locations and contacts
No sites are listed yet.
About this study
Cardiac Intensive Care Units (CICUs) provide care for a diverse patient population. Understanding the clinical characteristics, analysis of treatment modalities, and prognosis of patients hospitalized in the CICU are important to improve cardiovascular care. The purpose of this registry is to determine the demographics, clinical, treatment, and prognosis of patients hospitalized in the Polish CICUs. Data from this multicenter, prospective observational study will provide more robust data to facilitate quantitative characterization of cardiac care in contemporary Polish CICUs and enable the development of infrastructure for clinical trials in CICUs.
- Conditions
- Shock, Death, Cardiac Intensive Care Unit, Treatment Complication, Stroke, Multiple Organ Failure
- Medical subject headings
- Shock, Death, Stroke, Multiple Organ Failure, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
Measured: 01.10.2024 - 31.03.2025
Secondary outcomes (2)
Shock (cardiogenic/hypovolemic/anaphylactic/septic/neurogenic/obstructive)
Measured: 01.10.2024 - 31.03.2025
Treatment-related complications (tamponade, dissection, stroke, embolism, etc.)
Measured: 01.10.2024 - 31.03.2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Kowalik, MD, PhD, Principal investigator, 1st Department of Cardiology, Medical University of WarsawMonika Gawałko, MD, PhD, Principal investigator, 1st Department of Cardiology, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371677
- Sponsor's protocol ID
- KB/2024
- Acronym
- POL-CICU
- Status last verified
- Apr 2024
- First submitted
- 14 Apr 2024
- Last updated
- 17 Apr 2024
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polish Nationwide Register of Hospitalized Patients in Cardiac Intensive Care Units
- ClinicalTrials.gov ID
- NCT06371677
- Acronym / sponsor ID
- POL-CICU / KB/2024
- Conditions
- Shock, Death, Cardiac Intensive Care Unit, Treatment Complication, Stroke, Multiple Organ Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 17 Apr 2024 (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.
Cardiac Intensive Care Units (CICUs) provide care for a diverse patient population. Understanding the clinical characteristics, analysis of treatment modalities, and prognosis of patients hospitalized in the CICU are important to improve cardiovascular care. The purpose of this registry is to determine the demographics, clinical, treatment, and prognosis of patients hospitalized in the Polish CICUs. Data from this multicenter, prospective observational study will provide more robust data to facilitate quantitative characterization of cardiac care in contemporary Polish CICUs and enable the development of infrastructure for clinical trials in CICUs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients hospitalized at Polish CICUs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause death
Time frame: 01.10.2024 - 31.03.2025
2 secondary outcomes
Shock (cardiogenic/hypovolemic/anaphylactic/septic/neurogenic/obstructive)
Time frame: 01.10.2024 - 31.03.2025
Treatment-related complications (tamponade, dissection, stroke, embolism, etc.)
Time frame: 01.10.2024 - 31.03.2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Robert Kowalik, MD, PhD principal investigator
1st Department of Cardiology, Medical University of Warsaw
Monika Gawałko, MD, PhD principal investigator
1st Department of Cardiology, Medical University of Warsaw
Questions about this trial
What is this clinical trial studying?
An observational study of Shock and Death, run by Medical University of Warsaw.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Kowalik, MD, PhD (22 599 19 58 ext. +48, rjkowalik@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death (time frame: 01.10.2024 - 31.03.2025). 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 17 Apr 2024.