Severe SepsisMARSSNCT05231720
Mannheim Register of Sepsis and Septic Shock
An observational study of Severe Sepsis and Septic Shock, run by Universitätsmedizin Mannheim at 2 sites in Germany.
Trial summary
The study aims to investigate clinically and prognostically relevant parameters in patients with sepsis and septic shock within a monocentric observational clinical register. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Sepsis, Septic Shock
- How many people
- 500 participants
- Where
- 2 sitesGermany
- Study dates
- 3 Dec 2019to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes internal medicine patients presenting sepsis and septic shock at the ICU irrespective of the septic focus.
Who may be able to join
- Sepsis and septic shock according to current guidelines
Who cannot join
- other forms of shock not associated with an infection
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
University Medical Centre Mannheim
Mannheim, Baden-Wurttemberg, 76149
Michael Behnes, +496213836239, michael.behnes@umm.de
- 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
The study aims to investigate clinically and prognostically relevant parameters in patients with sepsis and septic shock within a monocentric observational clinical register.
Read the detailed description
All consecutive septic patients at the internists intensive care Unit (ICU) at the University of Mannheim are included in the register and follow up during ICU stay and after that. Data of patients' admission status, septic focus, 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 10). Standard scores for critically ill patients were calculated for the day before 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 septic patients' 1-year mortality.
- Conditions
- Severe Sepsis, Septic Shock
- Medical subject headings
- Sepsis, Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Measured: 30 days
Secondary outcomes (2)
all-cause mortality
Measured: in hospital
all-cause mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start3 Dec 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies 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
- 500 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
- NCT05231720
- Sponsor's protocol ID
- 2019-694N
- Acronym
- MARSS
- Status last verified
- Feb 2022
- First submitted
- 13 Jan 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Forner J, Weidner K, Rusnak J, Dudda J, Behnes M, Akin I, Schupp T. Prognostic Impact of Left Compared to Right Heart Function in Sepsis and Septic Shock. ASAIO J. 2024 Jun 1;70(6):502-509. doi: 10.1097/MAT.0000000000002131. Epub 2024 Jan 18.
PubMed 38237636
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mannheim Register of Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT05231720
- Acronym / sponsor ID
- MARSS / 2019-694N
- Conditions
- Severe Sepsis, Septic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Feb 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 sepsis and septic shock within a monocentric observational clinical register.
Detailed description
All consecutive septic patients at the internists intensive care Unit (ICU) at the University of Mannheim are included in the register and follow up during ICU stay and after that. Data of patients' admission status, septic focus, 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 10). Standard scores for critically ill patients were calculated for the day before 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 septic patients' 1-year mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes internal medicine patients presenting sepsis and septic shock at the ICU irrespective of the septic focus.
Key inclusion criteria (1 listed)
- Sepsis and septic shock according to current guidelines
Key exclusion criteria (1 listed)
- other forms of shock not associated with an infection
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
2 secondary outcomes
all-cause mortality
Time frame: in hospital
all-cause mortality
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Derived from this study: PubMed 38237636Forner J, Weidner K, Rusnak J, Dudda J, Behnes M, Akin I, Schupp T. Prognostic Impact of Left Compared to Right Heart Function in Sepsis and Septic Shock. ASAIO J. 2024 Jun 1;70(6):502-509. doi: 10.1097/MAT.0000000000002131. Epub 2024 Jan 18.
- 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.
First Department of Medicine, University Medical Centre Mannheim
Mannheim, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Septic Shock, run by Universitätsmedizin Mannheim at 2 sites 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 NCT05231720, which also lists 1 linked publication.
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 9 Feb 2022.