Sepsis in the ICU-II

NCT04695119 | Active Not Recruiting DMC

• 1 other identifier: SICU-II
• Study Type: observational
• Target: 379
• Locations: 2 countries
• Sites: 4

Brief 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. 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:

1. 1.To determine the association between left ventricular systolic and diastolic dysfunction, and adverse outcome in SIMD;
2. 2.To determine the association between right ventricular systolic and diastolic dysfunction, and adverse outcome in SIMD;
3. 3.To determine the association between novel biomarkers and adverse outcome in SIMD;
4. 4.To determine the combined value of biomarker, echocardiographic, and haemodynamic variables for predicting adverse outcomes in SIMD;
5. 5.To explore if there are different phenotypes of SIMD using unsupervised machine learning algorithms, and whether they are associated with adverse outcomes.

Conditions

Septic Shock; Sepsis; Cardiomyopathies; Organ Failure, Multiple

Outcome Measures

Primary Outcomes (2)

• Myocardial injury

  increased hsTnT

  any time during ICU stay within the study period, up to 10 days

• Organ failure free days

  Organ failure

  30 days of study inclusion

Secondary Outcomes (2)

• 30 day mortality

  30 days after study inclusion

• 365 day mortality

  365 days after study inclusion

Other Outcomes (3)

• Exploratory outcomes

  during ICU stay, up to 10 days

• Exploratory outcomes

  30 days of study inclusion

• Exploratory outcomes

  during ICU stay, up to 10 days

Study Arms (1)

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.

Other: Exposure is septic shock (defined according to Sepsis-III) and standard treatment according to departmental protocols.

Interventions

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.

Adult patients with septic shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Adult patients admitted to ICU and fulfilling the Sepsis-III criteria for septic shock

You may not qualify if:

• No informed consent
• Acute coronary syndromes

Sponsors & Collaborators

• Linkoeping University: lead
• Centre Hospitalier Universitaire Dijon: collaborator
• Ryhov County Hospital: collaborator
• Bicetre Hospital: collaborator
• European Georges Pompidou Hospital: collaborator

Study Sites (4)

CHU Dijon-Bourgogne

Dijon, 21000, France

Location

CHU Georges Pompidou

Paris, 75015, France

Location

Ryhov Sjukhus Jönköping

Jönköping, 55305, Sweden

Location

Dept of Anaesthesia and Intensive Care

Linköping, 58185, Sweden

Location

Related Publications (1)

• 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.

  PMID: 38236316 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma isolated neutrophils bronchoalveolar lavage

MeSH Terms

Conditions

Shock, Septic; Sepsis; Cardiomyopathies; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Heart Diseases; Cardiovascular Diseases

Study Officials

• Michelle Chew, MBBS, PhD

  Linkoeping University Hospital

  STUDY CHAIR

• Bernard Cholley, MD, PhD

  CHU George Pompidou

  PRINCIPAL INVESTIGATOR

• Belaid Bouhemad, MD, PhD

  CHU Dijon

  PRINCIPAL INVESTIGATOR

• Fredrik Hammarsköjld, MD, PhD

  Ryhov Hospital, Jönköping

  PRINCIPAL INVESTIGATOR

• Xavier Monnet, MD, PhD

  Hopital Bicetre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: January 5, 2021
• Study Start: September 17, 2018
• Primary Completion: February 11, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

FR (2); SE (2)