SepsisICROSNCT03620409
Identification of Cardiovascular and Molecular Prognostic Factors for the Mid- and Long-term Outcome of Sepsis
An observational study of Sepsis and Septic Cardiomyopathy, run by Jena University Hospital at 1 site in Germany.
Trial summary
Sepsis is a life-threatening condition which can affect people of any age. An infection triggers a host response resulting in organ failure. The extent of the organ dysfunction varies between patients and during the course of the condition. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Septic Cardiomyopathy, Cardiomyopathies
- How many people
- 308 participants
- Where
- 1 siteGermany
- Study dates
- 9 May 2018to 15 Jun 2022
- 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: primary care and community sample
Who may be able to join
- Patients with Sepsis:
- sepsis or septic shock according to Sepsis-3 criteria
- first infection-associated organ dysfunction (= sepsis diagnosis) no older than 72 hours (first blood sample within 96 hours after sepsis diagnosis)
- written informed consent of the patient or his legal representative
- Patients with cardiomyopathy without inflammation:
- cardiomyopathy without inflammation
Show all 9Show fewer
- written informed consent
- Healthy subjects:
- written informed consent
Who cannot join
- Patients with sepsis:
- cardiac surgery ≤ 12 months
- sepsis/septic shock ≤ 8 months
- significant pre-existing heart condition
- endocarditis
- higher-grade valvular heart disease (grade 3 valve disease, symptomatic aortic stenosis, medium-degree mitral valve insufficiency with reduced ejection fraction or clinical symptoms)
Show all 59Show fewer
- complex structural congenital heart disorders (e.g. TGA, Fallot-Tetralogie, endocardial cushion defect)
- pre-existing significantly reduced cardiac performance (ejection fraction < 45 % or 10 % below norm value)
- pre-existing pulmonary hypertension
- myocardial infarction ≤ 1 year in patient history
- heart transplantation in patient history
- permanent atrial fibrillation
- pneumectomy in medical history
- contraindication for transesophageal echocardiography (e.g. esophageal resection, higher-grade esophagus varices) and insufficient sonography conditions for transthoracic echocardiography
- liver cirrhosis Child C
- terminal kidney disease with dialysis
- pregnancy/breastfeeding
- previous participation in this study
- participation in another intervention study
- therapy limitation, DNR / DNI order
- life expectancy ≤ 6 months due to comorbidities
- cardiopulmonary resuscitation < 4 weeks before onset of sepsis
- Patients with cardiomyopathy without infection:
- sepsis/septic shock ≤ 8 months
- acute organ failure (except cardiac decompensation/cardiogenic shock due to dilated cardiomyopathy) ≤ 6 months due to infection
- complex structural congenital heart disorders (e.g. TGA, Fallot-Tetralogie, endocardial cushion defect)
- infection at point of inclusion
- cardiogenic shock at point of inclusion
- heart transplantation in medical history
- mechanical heart assist device
- pneumonectomy in medical history
- liver cirrhosis Child C
- terminal kidney disease with dialysis
- contraindication for transesophageal echocardiography (e.g. esophageal resection, higher-grade esophagus varices) and insufficient sonographic conditions for transthoracic echocardiography
- pregnancy/breastfeeding
- therapy limitation / DNR / DNI order
- life expectancy ≤ 6 months due to comorbidities
- previous participation in this study
- participation in another interventional study
- cardiopulmonary resuscitation < 4 weeks
- Healthy subjects:
- sepsis/septic shock ≤ 8 months
- ICU treatment ≤ 6 months
- infection at point of inclusion
- heart surgery (including heart transplantation) in medical history
- significant pre-existing cardiac condition
- higher-degree valvular heart disease (grade 3 valve disease, symptomatic aortic stenosis, medium-degree mitral valve insufficiency with reduced ejection fraction or clinical symptoms)
- complex structural congenital heart disorders (e.g. TGA, Fallot-Tetralogie, endocardial cushion defect)
- pre-existing significantly reduced cardiac performance (ejection fraction < 45 % or 10 % below norm value)
- pre-existing pulmonary hypertension
- myocardial infarction ≤ 1 year in medical history
- pneumonectomy in medical history
- liver cirrhosis Child C
- terminal kidney disease with dialysis
- contraindication for transesophageal echocardiography (e.g. esophageal resection, higher-grade esophagus varices) and insufficient sonography conditions for transthoracic echocardiography
- pregnancy/breastfeeding
- life expectancy ≤ 6 months due to comorbidities
- previous participation in this study
- participation in another intervention study
Trial locations and contacts
1 site in 1 country.
Germany1 site
NWG Translational Septomics, Zentrum für Innovationskomepetenz (ZIK) Septomics, Universitätklinikum Jena
Jena, Thuringia, D-07747
About this study
Sepsis is a life-threatening condition which can affect people of any age. An infection triggers a host response resulting in organ failure. The extent of the organ dysfunction varies between patients and during the course of the condition. Thus far, the only causal treatment option consists in treating the infection early e. g. by an operation or the use of antibiotics. Owing to advances in modern critical care, more patients survive sepsis. Nonetheless, sepsis survivors frequently show impaired organ function, physical disability and considerably decreased health-related quality of life.
It is hypothesized that sepsis-induced cardiac dysfunction - septic cardiomyopathy - may influence mortality. The relationship between occurrence of cardiovascular dysfunction and metabolic changes in the course of sepsis remains unclear. Therefore, the aim of this study is the investigation of cardiovascular function, oxygen consumption and metabolic changes in septic patients. Apart from cardiological routine procedures (echo- and electrocardiography) a newly developed method for measuring the oxygen tension and consumption, bioelectrical impedance analysis for body composition estimation and liver fibrosis assessment via transient elastography will be employed. Through blood, stool and urine analysis, both routine parameters and parameters focusing on patient metabolism will be analysed.
Read more
Septic patients will be assessed in the acute phase (3 and 7 days after sepsis diagnosis), the stable phase (at intensive care unit discharge) and after full or incomplete recovery (during two outpatient visits at 6 and 12 months after sepsis diagnosis). The results will be compared with healthy individuals and patients with existing heart disease (cardiomyopathy).
The study aims to identify clinical parameters and signaling pathways involved in the development and course of sepsis. Furthermore, specific parameters associated with the medium- and long-term health status, physical performance and quality of life after sepsis are to be identified. The overall aim of the study is the development of novel diagnostic and therapeutic approaches in sepsis.
Read the detailed description
The overall aim of the study is the identification of theragnostic targets for the development of novel diagnostic and therapeutic approaches in sepsis. In sepsis, a dysregulated host response to infection leads to organ failure. The extent of organ dysfunction varies between patients and at different stages of the disease. Advances in modern critical care have reduced 28-day mortality over the last years. Nonetheless, a large proportion of sepsis survivors reports long-term physical, mental and cognitive impairments (post intensive care syndrome) including persistent organ dysfunction (persistent critical illness). In addition, mortality rates are considerably increased up to years after sepsis. However, the underlying molecular mechanisms remain unclear.
There is evidence that the development of septic cardiomyopathy may influence mortality. The relationship between the occurrence of cardiovascular dysfunction and metabolic changes in the course of sepsis has not yet been investigated. Therefore, the key aim of this study is the investigation of cardiovascular function, oxygen consumption and metabolic changes in septic patients. Apart from cardiological routine procedures (echo- and electrocardiography) a newly developed method for measuring the mitochondrial oxygen tension and consumption (COMET) will be applied. As oedema is involved in the pathogenesis of altered microcirculation in sepsis, endothelial dysfunction will be analysed via a set of surrogate parameters and body composition (especially extracellular water) measurement via bioelectrical impedance analysis. Liver fibrosis will be assessed via transient elastography. In blood, stool and urine, routine parameters and the metabolome, lipidome and microbiome will be analysed. Septic patients will be assessed in the acute phase (3 and 7 days after sepsis diagnosis), the stable phase (at intensive care unit discharge) and after full or incomplete recovery (during two outpatient visits at 6 and 12 months sepsis diagnosis). Analyses will be complemented by in-depth anamnestic and clinical-epidemiological assessment as well as subsequent information on health related quality of life (EQ-5D-3L) and physical performance (6-minute walk test).
The primary endpoint of the study is the difference in mortality rates between septic patients with and without septic cardiomyopathy six months after sepsis diagnosis. Further research questions include differences in clinical and laboratory parameters between these patient groups during the acute phase, and during the mid-, and long-term course.
The results will be compared with healthy individuals and patients with cardiomyopathy in absence of infection.
- Conditions
- Sepsis, Septic Cardiomyopathy, Cardiomyopathies
- Medical subject headings
- Sepsis, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Patients with and without diagnosis septic cardiomyopathy Patients with and without suspected or confirmed SARS-CoV-2 infection | |
| Cardiomyopathy without infection | Patients without operation and patients with scheduled LVAD-Implantation | |
| Healthy subjects | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality differences between septic patients with vs. without septic cardiomyopathy six months after sepsis diagnosis
Difference in mortality rates between septic patients with vs. without septic cardiomyopathy six months after sepsis diagnosis
Measured: Six months after sepsis diagnosis
Secondary outcomes (2)
Mortality differences between septic patients with vs. without septic cardiomyopathy twelve months after sepsis diagnosis
Difference in mortality rates between septic patients with vs. without septic cardiomyopathy twelve months after sepsis diagnosis
Measured: Twelve months after sepsis diagnosis
Incidence of septic cardiomyopathy
Estimation of incidence of septic cardiomyopathy in the acute phase of sepsis
Measured: from enrollment until 3 days after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start9 May 2018
- Primary completion12 Oct 2021
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Prospective
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Biochemistry, Center for Molecular Biomedicine (CMB), FSU Jena, Systems Biology and Bioinformatics, Hans-Knöll Institute Jena, Institute of Pharmacy, FSU Jena
- Responsible party
- Principal investigator, Sina Coldewey, Jena University Hospital
- Investigators
- Sina M Coldewey, MD, PhD, Principal investigator, Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620409
- Sponsor's protocol ID
- ZKSJ106-V1.3
- Other IDs
- DRKS00013347
- Acronym
- ICROS
- Status last verified
- Mar 2023
- First submitted
- 15 May 2018
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Standke A, Neu C, Baumbach P, Plooij AK, Skitek K, Gotze J, Coldewey SM. Reversible impairment of non-invasively assessed mitochondrial oxygen metabolism in the long-term course of patients with sepsis: a prospective monocentric cohort study. Intensive Care Med Exp. 2025 Nov 14;13(1):114. doi: 10.1186/s40635-025-00808-x.
PubMed 41233688Coldewey SM, Neu C, Baumbach P, Scherag A, Goebel B, Ludewig K, Bloos F, Bauer M. Identification of cardiovascular and molecular prognostic factors for the medium-term and long-term outcomes of sepsis (ICROS): protocol for a prospective monocentric cohort study. BMJ Open. 2020 Jun 23;10(6):e036527. doi: 10.1136/bmjopen-2019-036527.
PubMed 32580988
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Cardiovascular and Molecular Prognostic Factors for the Mid- and Long-term Outcome of Sepsis
- ClinicalTrials.gov ID
- NCT03620409
- Acronym / sponsor ID
- ICROS / ZKSJ106-V1.3
- Conditions
- Sepsis, Septic Cardiomyopathy, Cardiomyopathies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- Department of Biochemistry, Center for Molecular Biomedicine (CMB), FSU Jena, Systems Biology and Bioinformatics, Hans-Knöll Institute Jena, Institute of Pharmacy, FSU Jena
- Study start
- 9 May 2018 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 8 Aug 2018 (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.
Sepsis is a life-threatening condition which can affect people of any age. An infection triggers a host response resulting in organ failure. The extent of the organ dysfunction varies between patients and during the course of the condition. Thus far, the only causal treatment option consists in treating the infection early e. g. by an operation or the use of antibiotics. Owing to advances in modern critical care, more patients survive sepsis. Nonetheless, sepsis survivors frequently show impaired organ function, physical disability and considerably decreased health-related quality of life.
It is hypothesized that sepsis-induced cardiac dysfunction - septic cardiomyopathy - may influence mortality. The relationship between occurrence of cardiovascular dysfunction and metabolic changes in the course of sepsis remains unclear. Therefore, the aim of this study is the investigation of cardiovascular function, oxygen consumption and metabolic changes in septic patients. Apart from cardiological routine procedures (echo- and electrocardiography) a newly developed method for measuring the oxygen tension and consumption, bioelectrical impedance analysis for body composition estimation and liver fibrosis assessment via transient elastography will be employed. Through blood, stool and urine analysis, both routine parameters and parameters focusing on patient metabolism will be analysed.
Septic patients will be assessed in the acute phase (3 and 7 days after sepsis diagnosis), the stable phase (at intensive care unit discharge) and after full or incomplete recovery (during two outpatient visits at 6 and 12 months after sepsis diagnosis). The results will be compared with healthy individuals and patients with existing heart disease (cardiomyopathy).
The study aims to identify clinical parameters and signaling pathways involved in the development and course of sepsis. Furthermore, specific parameters associated with the medium- and long-term health status, physical performance and quality of life after sepsis are to be identified. The overall aim of the study is the development of novel diagnostic and therapeutic approaches in sepsis.
Detailed description
The overall aim of the study is the identification of theragnostic targets for the development of novel diagnostic and therapeutic approaches in sepsis. In sepsis, a dysregulated host response to infection leads to organ failure. The extent of organ dysfunction varies between patients and at different stages of the disease. Advances in modern critical care have reduced 28-day mortality over the last years. Nonetheless, a large proportion of sepsis survivors reports long-term physical, mental and cognitive impairments (post intensive care syndrome) including persistent organ dysfunction (persistent critical illness). In addition, mortality rates are considerably increased up to years after sepsis. However, the underlying molecular mechanisms remain unclear.
There is evidence that the development of septic cardiomyopathy may influence mortality. The relationship between the occurrence of cardiovascular dysfunction and metabolic changes in the course of sepsis has not yet been investigated. Therefore, the key aim of this study is the investigation of cardiovascular function, oxygen consumption and metabolic changes in septic patients. Apart from cardiological routine procedures (echo- and electrocardiography) a newly developed method for measuring the mitochondrial oxygen tension and consumption (COMET) will be applied. As oedema is involved in the pathogenesis of altered microcirculation in sepsis, endothelial dysfunction will be analysed via a set of surrogate parameters and body composition (especially extracellular water) measurement via bioelectrical impedance analysis. Liver fibrosis will be assessed via transient elastography. In blood, stool and urine, routine parameters and the metabolome, lipidome and microbiome will be analysed. Septic patients will be assessed in the acute phase (3 and 7 days after sepsis diagnosis), the stable phase (at intensive care unit discharge) and after full or incomplete recovery (during two outpatient visits at 6 and 12 months sepsis diagnosis). Analyses will be complemented by in-depth anamnestic and clinical-epidemiological assessment as well as subsequent information on health related quality of life (EQ-5D-3L) and physical performance (6-minute walk test).
The primary endpoint of the study is the difference in mortality rates between septic patients with and without septic cardiomyopathy six months after sepsis diagnosis. Further research questions include differences in clinical and laboratory parameters between these patient groups during the acute phase, and during the mid-, and long-term course.
The results will be compared with healthy individuals and patients with cardiomyopathy in absence of infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | –Patients with and without diagnosis septic cardiomyopathy Patients with and without suspected or confirmed SARS-CoV-2 infection |
| Cardiomyopathy without infection | – | –Patients without operation and patients with scheduled LVAD-Implantation |
| Healthy subjects | – | –Healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care and community sample
Key inclusion criteria (9 listed)
- sepsis or septic shock according to Sepsis-3 criteria
- first infection-associated organ dysfunction (= sepsis diagnosis) no older than 72 hours (first blood sample within 96 hours after sepsis diagnosis)
- written informed consent of the patient or his legal representative
- cardiomyopathy without inflammation
- written informed consent
Key exclusion criteria (59 listed)
- cardiac surgery ≤ 12 months
- sepsis/septic shock ≤ 8 months
- significant pre-existing heart condition
- pneumectomy in medical history
- contraindication for transesophageal echocardiography (e.g. esophageal resection, higher-grade esophagus varices) and insufficient sonography conditions for transthoracic echocardiography
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
Mortality differences between septic patients with vs. without septic cardiomyopathy six months after sepsis diagnosis
Time frame: Six months after sepsis diagnosis
Difference in mortality rates between septic patients with vs. without septic cardiomyopathy six months after sepsis diagnosis
2 secondary outcomes
Mortality differences between septic patients with vs. without septic cardiomyopathy twelve months after sepsis diagnosis
Time frame: Twelve months after sepsis diagnosis
Incidence of septic cardiomyopathy
Time frame: from enrollment until 3 days after ICU 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 13 Mar 2023.
- Derived from this study: PubMed 41233688Standke A, Neu C, Baumbach P, Plooij AK, Skitek K, Gotze J, Coldewey SM. Reversible impairment of non-invasively assessed mitochondrial oxygen metabolism in the long-term course of patients with sepsis: a prospective monocentric cohort study. Intensive Care Med Exp. 2025 Nov 14;13(1):114. doi: 10.1186/s40635-025-00808-x.
- Derived from this study: PubMed 32580988Coldewey SM, Neu C, Baumbach P, Scherag A, Goebel B, Ludewig K, Bloos F, Bauer M. Identification of cardiovascular and molecular prognostic factors for the medium-term and long-term outcomes of sepsis (ICROS): protocol for a prospective monocentric cohort study. BMJ Open. 2020 Jun 23;10(6):e036527. doi: 10.1136/bmjopen-2019-036527.
- HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Sina M Coldewey, MD, PhD principal investigator
Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital
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 Sepsis and Septic Cardiomyopathy, run by Jena University Hospital 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 9 inclusion and 59 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 13 Mar 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 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?
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?
Mortality differences between septic patients with vs. without septic cardiomyopathy six months after sepsis diagnosis (time frame: Six months after sepsis diagnosis). 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 NCT03620409, which also lists 2 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 13 Mar 2023.