Septic ShockNCT04695119
Sepsis in the ICU-II
An observational study of Septic Shock and Sepsis, run by Linkoeping University at 4 sites in 2 countries.
Trial summary
Sepsis-induced cardiac dysfunction (SIMD) is a well-known phenomenon yet its diagnosis remains elusive with no accepted definition, or defining pathophysiological mechanism associated with this disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Sepsis, Cardiomyopathies
- What is being tested?
- Exposure is septic shock (defined according to Sepsis-III) and standard treatment according to departmental protocols.
- How many people
- 379 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 17 Sep 2018to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All consecutive patients admitted to participating ICUs with a presumptive diagnosis of septic shock will be screened for eligibility. Patients fulfilling the Sepsis-III criteria for septic shock will included. Study inclusion must occur within 12h of ICU admission.
Who may be able to join
- Adult patients admitted to ICU and fulfilling the Sepsis-III criteria for septic shock
Who cannot join
- No informed consent
- Acute coronary syndromes
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France2 sites
CHU Dijon-Bourgogne
Dijon, 21000
CHU Georges Pompidou
Paris, 75015
Sweden2 sites
Ryhov Sjukhus Jönköping
Jönköping, 55305
Dept of Anaesthesia and Intensive Care
Linköping, 58185
About this study
Official title: Sepsis in the Intensive Care Unit-II
Sepsis-induced cardiac dysfunction (SIMD) is a well-known phenomenon yet its diagnosis remains elusive with no accepted definition, or defining pathophysiological mechanism associated with this disease. Systolic dysfunction occurs in 20-70% of patients, and may be severe, yet does not appear to have any prognostic value for mortality. Diastolic function has also been variably described and seems to be related to short-term mortality. However, the contribution of left ventricular systolic and diastolic dysfunction to mortality in sepsis are still far from clear, with uncertain contribution from previous cardiovascular disease, vasopressor and inotropic drugs and mechanical ventilation. Another poorly investigated area is right ventricular dysfunction. Cor pulmonale occurs in up to 25% of patients with septic shock, and is invariably related to pulmonary haemodynamics and mechanical ventilation, yet very little is known about how this affects prognosis. Finally, although the outcome of disease is a function of multiple parameters, septic cardiomyopathy is most frequently characterized based on individual echocardiographic parameters, without considering their interactions or placing them in the context of biomarkers and clinically available haemodynamic data. Available relevant studies are often monocentric, and many fail to consider the various confounders that influence the clinical outcome in sepsis. Therefore, the diagnostic and prognostic value of combinations of clinical, biochemical and haemodynamic variables remains to be established.
Accordingly, the purpose of this study is to identify biomarkers and echocardiographic and haemodynamic signatures characteristic of specific outcomes in SIMD to support the diagnosis and prognosis in SIMD. Specific aims are:
Read more
- To determine the association between left ventricular systolic and diastolic dysfunction, and adverse outcome in SIMD;
- To determine the association between right ventricular systolic and diastolic dysfunction, and adverse outcome in SIMD;
- To determine the association between novel biomarkers and adverse outcome in SIMD;
- To determine the combined value of biomarker, echocardiographic, and haemodynamic variables for predicting adverse outcomes in SIMD;
- To explore if there are different phenotypes of SIMD using unsupervised machine learning algorithms, and whether they are associated with adverse outcomes.
50 patients will be enrolled in a feasibility study to evaluate the logistical setup for acute echocardiography and biobanking facilities. A further 280 patients will be enrolled with inclusion from peripheral centers once feasibility is confirmed.
Note 15 Mar 2026: typing mistake noted in prior text, the sample size was originally for 330 patients (i.e. 50 + 280), not 350 (50 + 300) patients.
Read the detailed description
UPDATE 26 Feb 2022:
A pilot project was completedafter recruitment of 50 patients confirming the feasibility of data collection, study logistics, biomarker assay set-up and frequency of outcomes. Cancellation of non-COVID related research in 2020\&2021 has caused significant delays. Recruitment of patients will continue during 2022\&2023. At the time of writing 70 patients have been recruited across 4 centres.
UPDATE 15 Mar 2026:
At the steering committee meeting on 12 August 2024, the principal investigator presented population characteristics of the first 49 patients in the feasibility phase and compared them with the subsequent 231 recruited patients. The two cohorts were similar in age and sex, but the later cohort had higher median SAPS II scores, greater use of organ support, and higher ICU and 30-day mortality. Discussions with recruiting sites indicated that the COVID-19 pandemic had substantially changed the case-mix of ICU admissions; nursing staff shortages and bed closures led to admission of more severely ill patients, particularly at the major recruiting site. The steering committee concluded that there was no need to deviate from the original protocol but recommended recruitment of an additional 49 patients to reduce potential heterogeneity in the underlying population. The total target sample size was therefore set at 379 patients. The expanded sample size was approved by the Swedish Ethical Review Authority on 7 Feb 2025.
- Conditions
- Septic Shock, Sepsis, Cardiomyopathies, Organ Failure, Multiple
- Being tested
- Exposure is septic shock (defined according to Sepsis-III) and standard treatment according to departmental protocols.
- Medical subject headings
- Shock, Septic, Sepsis, Cardiomyopathies, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure is septic shock (defined according to Sepsis-III) and standard treatment according to departmental protocols.Other
Collection of data, biomarker and echocardiography analysis will be centralized and blinded. Assessment of endpoints will be blinded.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with septic shock | All adult (>=18 yo) patients admitted to participating ICUs with septic shock defined according to the Sepsis III criteria.
Purely observation study with no intervention. Patients are exposed to septic shock and treatment according to standard departmental protocols at each centre. Receives: Other: Exposure is septic shock (defined according to Sepsis-III) and standard treatment according to departmental protocols. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial injury
increased hsTnT
Measured: any time during ICU stay within the study period, up to 10 days
Organ failure free days
Organ failure
Measured: 30 days of study inclusion
Secondary outcomes (2)
30 day mortality
Short term mortality
Measured: 30 days after study inclusion
365 day mortality
Long term mortality
Measured: 365 days after study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start17 Sep 2018
- Primary completion11 Feb 2026
- Study completion31 Dec 2027 (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 Septic 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
- Prospective
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Centre Hospitalier Universitaire Dijon, Ryhov County Hospital, Bicetre Hospital, European Georges Pompidou Hospital
- Responsible party
- Principal investigator, Michelle Chew, Linkoeping University
- Investigators
- Michelle Chew, MBBS, PhD, Study chair, Linkoeping University HospitalBernard Cholley, MD, PhD, Principal investigator, CHU George PompidouBelaid Bouhemad, MD, PhD, Principal investigator, CHU DijonFredrik Hammarsköjld, MD, PhD, Principal investigator, Ryhov Hospital, JönköpingXavier Monnet, MD, PhD, Principal investigator, Hopital Bicetre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695119
- Sponsor's protocol ID
- SICU-II
- Status last verified
- Mar 2026
- First submitted
- 21 Dec 2020
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blixt PJ, Nguyen M, Cholley B, Hammarskjold F, Toiron A, Bouhemad B, Lee S, De Geer L, Andersson H, Aneq MA, Engvall J, Chew MS. Association between left ventricular systolic function parameters and myocardial injury, organ failure and mortality in patients with septic shock. Ann Intensive Care. 2024 Jan 18;14(1):12. doi: 10.1186/s13613-023-01235-5.
PubMed 38236316
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sepsis in the Intensive Care Unit-II
- ClinicalTrials.gov ID
- NCT04695119
- Acronym / sponsor ID
- SICU-II
- Conditions
- Septic Shock, Sepsis, Cardiomyopathies, Organ Failure, Multiple
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Centre Hospitalier Universitaire Dijon, Ryhov County Hospital, Bicetre Hospital, European Georges Pompidou Hospital
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Jan 2021 (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-induced cardiac dysfunction (SIMD) is a well-known phenomenon yet its diagnosis remains elusive with no accepted definition, or defining pathophysiological mechanism associated with this disease. Systolic dysfunction occurs in 20-70% of patients, and may be severe, yet does not appear to have any prognostic value for mortality. Diastolic function has also been variably described and seems to be related to short-term mortality. However, the contribution of left ventricular systolic and diastolic dysfunction to mortality in sepsis are still far from clear, with uncertain contribution from previous cardiovascular disease, vasopressor and inotropic drugs and mechanical ventilation. Another poorly investigated area is right ventricular dysfunction. Cor pulmonale occurs in up to 25% of patients with septic shock, and is invariably related to pulmonary haemodynamics and mechanical ventilation, yet very little is known about how this affects prognosis. Finally, although the outcome of disease is a function of multiple parameters, septic cardiomyopathy is most frequently characterized based on individual echocardiographic parameters, without considering their interactions or placing them in the context of biomarkers and clinically available haemodynamic data. Available relevant studies are often monocentric, and many fail to consider the various confounders that influence the clinical outcome in sepsis. Therefore, the diagnostic and prognostic value of combinations of clinical, biochemical and haemodynamic variables remains to be established.
Accordingly, the purpose of this study is to identify biomarkers and echocardiographic and haemodynamic signatures characteristic of specific outcomes in SIMD to support the diagnosis and prognosis in SIMD. Specific aims are:
- To determine the association between left ventricular systolic and diastolic dysfunction, and adverse outcome in SIMD;
- To determine the association between right ventricular systolic and diastolic dysfunction, and adverse outcome in SIMD;
- To determine the association between novel biomarkers and adverse outcome in SIMD;
- To determine the combined value of biomarker, echocardiographic, and haemodynamic variables for predicting adverse outcomes in SIMD;
- To explore if there are different phenotypes of SIMD using unsupervised machine learning algorithms, and whether they are associated with adverse outcomes.
50 patients will be enrolled in a feasibility study to evaluate the logistical setup for acute echocardiography and biobanking facilities. A further 280 patients will be enrolled with inclusion from peripheral centers once feasibility is confirmed.
Note 15 Mar 2026: typing mistake noted in prior text, the sample size was originally for 330 patients (i.e. 50 + 280), not 350 (50 + 300) patients.
Detailed description
UPDATE 26 Feb 2022:
A pilot project was completedafter recruitment of 50 patients confirming the feasibility of data collection, study logistics, biomarker assay set-up and frequency of outcomes. Cancellation of non-COVID related research in 2020\&2021 has caused significant delays. Recruitment of patients will continue during 2022\&2023. At the time of writing 70 patients have been recruited across 4 centres.
UPDATE 15 Mar 2026:
At the steering committee meeting on 12 August 2024, the principal investigator presented population characteristics of the first 49 patients in the feasibility phase and compared them with the subsequent 231 recruited patients. The two cohorts were similar in age and sex, but the later cohort had higher median SAPS II scores, greater use of organ support, and higher ICU and 30-day mortality. Discussions with recruiting sites indicated that the COVID-19 pandemic had substantially changed the case-mix of ICU admissions; nursing staff shortages and bed closures led to admission of more severely ill patients, particularly at the major recruiting site. The steering committee concluded that there was no need to deviate from the original protocol but recommended recruitment of an additional 49 patients to reduce potential heterogeneity in the underlying population. The total target sample size was therefore set at 379 patients. The expanded sample size was approved by the Swedish Ethical Review Authority on 7 Feb 2025.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with septic shock | – | Other: Exposure is septic shock (defined according to Sepsis-III) and standard treatment according to departmental protocols.All adult (>=18 yo) patients admitted to participating ICUs with septic shock defined according to the Sepsis III criteria. Purely observation study with no intervention. Patients are exposed to septic shock and treatment according to standard departmental protocols at each centre. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients admitted to participating ICUs with a presumptive diagnosis of septic shock will be screened for eligibility. Patients fulfilling the Sepsis-III criteria for septic shock will included. Study inclusion must occur within 12h of ICU admission.
Key inclusion criteria (1 listed)
- Adult patients admitted to ICU and fulfilling the Sepsis-III criteria for septic shock
Key exclusion criteria (2 listed)
- No informed consent
- Acute coronary syndromes
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 |
|---|---|---|
| Exposure is septic shock (defined according to Sepsis-III) and standard treatment according to departmental protocols.Collection of data, biomarker and echocardiography analysis will be centralized and blinded. Assessment of endpoints will be blinded. | Other | Adult patients with septic shock |
Primary outcome
Myocardial injury
Time frame: any time during ICU stay within the study period, up to 10 days
increased hsTnT
Organ failure free days
Time frame: 30 days of study inclusion
Organ failure
2 secondary outcomes
30 day mortality
Time frame: 30 days after study inclusion
365 day mortality
Time frame: 365 days after study inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Derived from this study: PubMed 38236316Blixt PJ, Nguyen M, Cholley B, Hammarskjold F, Toiron A, Bouhemad B, Lee S, De Geer L, Andersson H, Aneq MA, Engvall J, Chew MS. Association between left ventricular systolic function parameters and myocardial injury, organ failure and mortality in patients with septic shock. Ann Intensive Care. 2024 Jan 18;14(1):12. doi: 10.1186/s13613-023-01235-5.
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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.
Michelle Chew, MBBS, PhD study chair
Linkoeping University Hospital
Bernard Cholley, MD, PhD principal investigator
CHU George Pompidou
Belaid Bouhemad, MD, PhD principal investigator
CHU Dijon
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Sepsis, run by Linkoeping University at 4 sites in 2 countries.
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 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: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Myocardial injury (time frame: any time during ICU stay within the study period, up to 10 days). The study lists 2 primary outcomes in all. 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 NCT04695119, 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 17 Mar 2026.