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

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

Sponsors & Collaborators

• Department of Anesthesiology and Intensive Care Medicine, JUH

  collaborator UNKNOWN

• Department of Cardiothoracic Surgery, JUH

  collaborator UNKNOWN

• Department of Clinical Chemistry and Laboratory Medicine, JUH

  collaborator UNKNOWN

• Department of Biochemistry, Center for Molecular Biomedicine (CMB), FSU Jena

  collaborator UNKNOWN

• Systems Biology and Bioinformatics, Hans-Knöll Institute Jena

  collaborator UNKNOWN

• Institute of Pharmacy, FSU Jena

  collaborator UNKNOWN

• Jena University Hospital

  lead OTHER

Principal Investigators

• Sina M Coldewey, MD, PhD · Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-05-09

Primary Completion

2021-10-12

Completion

2022-06-15

Countries

• Germany

Study Locations