Identification of Cardiovascular and Molecular Prognostic Factors for the Mid- and Long-term Outcome of Sepsis

NCT03620409 | Completed DMC

• 2 other identifiers: ZKSJ106-V1.3DRKS00013347
• Study Type: observational
• Target: 308
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sepsis; Septic Cardiomyopathy; Cardiomyopathies

Outcome Measures

Primary Outcomes (1)

• 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

  Six months after sepsis diagnosis

Secondary Outcomes (2)

• Mortality differences between septic patients with vs. without septic cardiomyopathy twelve months after sepsis diagnosis

  Twelve months after sepsis diagnosis

• Incidence of septic cardiomyopathy

  from enrollment until 3 days after ICU discharge

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care and community sample

You may qualify if:

• 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
• written informed consent
• Healthy subjects:
• \- written informed consent

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Jena University Hospital: lead
• Department of Anesthesiology and Intensive Care Medicine, JUH: collaborator
• Department of Cardiothoracic Surgery, JUH: collaborator
• Department of Clinical Chemistry and Laboratory Medicine, JUH: collaborator
• Department of Biochemistry, Center for Molecular Biomedicine (CMB), FSU Jena: collaborator
• Systems Biology and Bioinformatics, Hans-Knöll Institute Jena: collaborator
• Institute of Pharmacy, FSU Jena: collaborator

Study Sites (1)

NWG Translational Septomics, Zentrum für Innovationskomepetenz (ZIK) Septomics, Universitätklinikum Jena

Jena, Thuringia, D-07747, Germany

Location

Related Publications (2)

• 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.

  PMID: 41233688 DERIVED

• Coldewey 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.

  PMID: 32580988 DERIVED

Related Links

• Homepage

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine and stool samples.

MeSH Terms

Conditions

Sepsis; Cardiomyopathies

Condition Hierarchy (Ancestors)

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

Study Officials

• Sina M Coldewey, MD, PhD

  Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: August 8, 2018
• Study Start: May 9, 2018
• Primary Completion: October 12, 2021
• Study Completion: June 15, 2022
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)