Cardiogenic ShockCARESMANCT05575856
Cardiogenic Shock Registry Mannheim
An observational study of Cardiogenic Shock, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
The study aims to investigate clinically and prognostically relevant parameters in patients with cardiogenic shock within a monocentric observational clinical register. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- How many people
- 350 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2019to 1 Dec 2023
- How long will I take part?
- 1 Year
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes all patients presenting with a cardiogenic shock at the intensive care unit (ICU).
Who may be able to join
- Cardiogenic shock according to current guidelines
Who cannot join
- other forms of shock not primary associated with cardiac dysfunction
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
First Department of Medicine, University Medical Centre Mannheim
Mannheim, 68167
Ibrahim Akin, MD, PhD, 0049621-3836239, ibrahim.akin@umm.de
Michael Behnes, MD, PhD, 0049621-3836239, michael.behnes@umm.de
About this study
Official title: Cardiogenic Shock Registry Mannheim - CARESMA
The study aims to investigate clinically and prognostically relevant parameters in patients with cardiogenic shock within a monocentric observational clinical register.
Read the detailed description
All consecutive patients with a confirmed cardiogenic shock presenting at the internal intensive care Unit (ICU) at the University of Mannheim are included in the register and followed up during ICU stay and after that. Data of patients' admission status, cause of cardiogenic shock, baseline parameters and comorbidities are collected. Extensive information about echocardiography, electrocardiography and imaging procedures are included in the register. Laboratory values, microbiological investigations, organ dysfunction and organ replacement therapies, medication, adverse events, and complications were recorded for several days during the ICU stay (days 1, 2, 3, 5, 7, and 8). Standard scores for critically ill patients were calculated for the day of admission at the ICU if available, and several time points during the ICU stay. The register includes information about the mortality during ICU stay, 30-day mortality, 6-month mortality and 1-year mortality.
- Conditions
- Cardiogenic Shock
- Keywords
- cardiogenic shock, heart failure, cardiac arrest, shock, acute myocardial infarction
- Medical subject headings
- Shock, Cardiogenic, Heart Failure, Heart Arrest, Shock
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
days
Measured: 30 days
Secondary outcomes (3)
all-cause mortality
during hospital stay (up to 30 days)
Measured: during hospital stay (up to 30 days)
all-cause mortality
years
Measured: 1 years
ventilator-free days
days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Jun 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies 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
- Cross-sectional
- Enrolment
- 350 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Behnes, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575856
- Sponsor's protocol ID
- 2019-695N
- Acronym
- CARESMA
- Status last verified
- Oct 2022
- First submitted
- 12 Mar 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rusnak J, Schupp T, Weidner K, Ruka M, Egner-Walter S, Schmitt A, Akin M, Tajti P, Mashayekhi K, Ayoub M, Behnes M, Akin I. Prognostic Influence of Lung Compliance in Patients with Cardiogenic Shock and Invasive Mechanical Ventilation. Rev Cardiovasc Med. 2024 Nov 22;25(11):420. doi: 10.31083/j.rcm2511420. eCollection 2024 Nov.
PubMed 39618866Rusnak J, Schupp T, Weidner K, Ruka M, Egner-Walter S, Forner J, Schmitt A, Akin M, Tajti P, Mashayekhi K, Ayoub M, Akin I, Behnes M. Influence of Right and Left Bundle Branch Block in Patients With Cardiogenic Shock and Cardiac Arrest. Crit Care Med. 2025 Jan 1;53(1):e54-e64. doi: 10.1097/CCM.0000000000006459. Epub 2024 Oct 29.
PubMed 39470337Schupp T, Rusnak J, Forner J, Dudda J, Bertsch T, Behnes M, Akin I. Platelet Count During Course of Cardiogenic Shock. ASAIO J. 2024 Jan 1;70(1):44-52. doi: 10.1097/MAT.0000000000002066. Epub 2023 Oct 12.
PubMed 37831815Behnes M, Rusnak J, Egner-Walter S, Ruka M, Dudda J, Schmitt A, Forner J, Mashayekhi K, Tajti P, Ayoub M, Weiss C, Akin I, Schupp T. Effect of Admission and Onset Time on the Prognosis of Patients With Cardiogenic Shock. Chest. 2024 Jan;165(1):110-127. doi: 10.1016/j.chest.2023.08.011. Epub 2023 Aug 12.
PubMed 37579943Schmitt A, Schupp T, Rusnak J, Ruka M, Egner-Walter S, Mashayekhi K, Tajti P, Ayoub M, Behnes M, Akin I, Weidner K. Does sex affect the risk of 30-day all-cause mortality in cardiogenic shock? Int J Cardiol. 2023 Jun 15;381:105-111. doi: 10.1016/j.ijcard.2023.03.061. Epub 2023 Mar 31.
PubMed 37004944
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiogenic Shock Registry Mannheim - CARESMA
- ClinicalTrials.gov ID
- NCT05575856
- Acronym / sponsor ID
- CARESMA / 2019-695N
- Conditions
- Cardiogenic Shock
- Keywords
- cardiogenic shock, heart failure, cardiac arrest, shock, acute myocardial infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 12 Oct 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.
The study aims to investigate clinically and prognostically relevant parameters in patients with cardiogenic shock within a monocentric observational clinical register.
Detailed description
All consecutive patients with a confirmed cardiogenic shock presenting at the internal intensive care Unit (ICU) at the University of Mannheim are included in the register and followed up during ICU stay and after that. Data of patients' admission status, cause of cardiogenic shock, baseline parameters and comorbidities are collected. Extensive information about echocardiography, electrocardiography and imaging procedures are included in the register. Laboratory values, microbiological investigations, organ dysfunction and organ replacement therapies, medication, adverse events, and complications were recorded for several days during the ICU stay (days 1, 2, 3, 5, 7, and 8). Standard scores for critically ill patients were calculated for the day of admission at the ICU if available, and several time points during the ICU stay. The register includes information about the mortality during ICU stay, 30-day mortality, 6-month mortality and 1-year mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes all patients presenting with a cardiogenic shock at the intensive care unit (ICU).
Key inclusion criteria (1 listed)
- Cardiogenic shock according to current guidelines
Key exclusion criteria (1 listed)
- other forms of shock not primary associated with cardiac dysfunction
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 mortality
Time frame: 30 days
days
3 secondary outcomes
all-cause mortality
Time frame: during hospital stay (up to 30 days)
all-cause mortality
Time frame: 1 years
ventilator-free days
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Derived from this study: PubMed 39618866Rusnak J, Schupp T, Weidner K, Ruka M, Egner-Walter S, Schmitt A, Akin M, Tajti P, Mashayekhi K, Ayoub M, Behnes M, Akin I. Prognostic Influence of Lung Compliance in Patients with Cardiogenic Shock and Invasive Mechanical Ventilation. Rev Cardiovasc Med. 2024 Nov 22;25(11):420. doi: 10.31083/j.rcm2511420. eCollection 2024 Nov.
- Derived from this study: PubMed 39470337Rusnak J, Schupp T, Weidner K, Ruka M, Egner-Walter S, Forner J, Schmitt A, Akin M, Tajti P, Mashayekhi K, Ayoub M, Akin I, Behnes M. Influence of Right and Left Bundle Branch Block in Patients With Cardiogenic Shock and Cardiac Arrest. Crit Care Med. 2025 Jan 1;53(1):e54-e64. doi: 10.1097/CCM.0000000000006459. Epub 2024 Oct 29.
- Derived from this study: PubMed 37831815Schupp T, Rusnak J, Forner J, Dudda J, Bertsch T, Behnes M, Akin I. Platelet Count During Course of Cardiogenic Shock. ASAIO J. 2024 Jan 1;70(1):44-52. doi: 10.1097/MAT.0000000000002066. Epub 2023 Oct 12.
- Derived from this study: PubMed 37579943Behnes M, Rusnak J, Egner-Walter S, Ruka M, Dudda J, Schmitt A, Forner J, Mashayekhi K, Tajti P, Ayoub M, Weiss C, Akin I, Schupp T. Effect of Admission and Onset Time on the Prognosis of Patients With Cardiogenic Shock. Chest. 2024 Jan;165(1):110-127. doi: 10.1016/j.chest.2023.08.011. Epub 2023 Aug 12.
- Derived from this study: PubMed 37004944Schmitt A, Schupp T, Rusnak J, Ruka M, Egner-Walter S, Mashayekhi K, Tajti P, Ayoub M, Behnes M, Akin I, Weidner K. Does sex affect the risk of 30-day all-cause mortality in cardiogenic shock? Int J Cardiol. 2023 Jun 15;381:105-111. doi: 10.1016/j.ijcard.2023.03.061. Epub 2023 Mar 31.
- Individual participant dataSharing planned: No
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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.
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 Cardiogenic Shock, run by Universitätsmedizin Mannheim at 1 site in Germany.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Oct 2022. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Behnes, PhD (0049621-3836239, michael.behnes@umm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05575856, which also lists 5 linked publications.
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 12 Oct 2022.