Identification of cardiovascular and molecular prognostic factors for the mid- and long-term outcome of sepsis

Identification of cardiovascular and molecular prognostic factors for the mid- and long-term outcome of sepsis - ICROS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00013347

Enrollment

290

Registered

2017-11-30

Start date

2018-05-09

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A41.9

Interventions

Group 1: Sepsis (diagnosis septic cardiomyopathy: yes/no): Patients without SARS-CoV2 infection - Routine and study-specific blood tests (incl. analysis of immune status, metabolites, lipids and mito

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Arm 1: • 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) • age > 18 years • written informed consent of the patient or his legal representative Arm 2: • dilated cardiomyopathy • age > 18 years • written informed consent Arm 3: • age > 18 years • written informed consent

Exclusion criteria

Exclusion criteria: Arm 1: • cardiac surgery = 12 months • significant pre-existing heart condition o endocarditis o higher-grade valvular heart disease (grade 3 valve disease, symptomatic aortic stenosis, medium-degree mitral valve insufficiency with reduced ejection fraction or clinical symptoms) o complex structural congenital heart condition (TGA, Tetralogy of Fallot, endocardial cushion defect etc.) o hemodynamic relevant shunt deficit o pre-existing significantly reduced cardiac performance (ejection fraction < 45 % or 10 % below norm value) o pre-existing pulmonary hypertension o myocardial infarction = 1 year in patient history o heart transplantation in patient history • cardiopulmonary resuscitation<4 weeks • pneumonectomy in medical history • liver cirrhosis Child C • contraindication for transesophageal echocardiography (e.g. esophageal resection, higher-grade esophagus varices) and insufficient sonography conditions for transthoracic echocardiography • terminal kidney disease with dialysis • Sepsis/septic shock = 8 months • pregnancy/breastfeeding • therapy limitation, DNR / DNI order • life expectancy = 6 months due to comorbidities • previous participation in this study • participation in another intervention study Arm 2 • Sepsis/septic shock = 8 months • infection at point of inclusion • acute organ failure (except cardiac decompensation/cardiogenic shock due to dilated cardiomyopathy) = 6 months • cardiopulmonary resuscitation<4 weeks • complex structural congenital heart condition (TGA, Tetralogy of Fallot, endocardial cushion defect etc.) • hemodynamic relevant shunt deficit • cardiogenic shock (INTERMACS 1) at point of inclusion • heart transplantation in medical history • mechanical heart supporting system • pneumonectomy in medical history • liver cirrhosis Child C • terminal kidney disease with dialysis • 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 intervention study Arm 3 • sepsis/septic shock = 8 months • infection at point of inclusion • ICU treatment = 6 months • cardiopulmonary resuscitation<4 weeks • heart surgery (including heart transplantation) in medical history • significant pre-existing cardiac condition o higher-degree valvular heart disease (grade 3 valve disease, symptomatic aortic stenosis, medium-degree mitral valve insufficiency with reduced ejection fraction or clinical symptoms) o complex structural congenital heart condition (TGA, Tetralogy of Fallot, endocardial cushion defect etc.) o hemodynamic relevant shunt deficit o cardiomyopathy o pre-existing significantly reduced cardiac performance (ejection fraction < 45 % or 10 % below norm value) o pre-existing pulmonary hypertension o myocardial infarction = 1 year in medical history • pneumonectomy in medical history • liver cirrhosis Child C • terminal kidney disease with dialysis • 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

Design outcomes

Primary

Measure	Time frame
Difference in mortality rates between septic patients with and without septic cardiomyopathy six months after sepsis diagnosis	—

Secondary

Measure	Time frame
- Difference in mortality rates between septic patients with or without septic cardiomyopathy twelve months after sepsis diagnosis Estimation of incidence of septic cardiomyopathy in the acute phase of sepsis To address further research questions, the parameters from the following methods will be analysed: cardiovascular risk-factors and function (echocardiography), body composition (especially extracellular body water, bioelectrical impedance analysis), organ dysfunctions, immune-status, metabolome, lipidome, microbiome, function of the autonomic nervous system (Holter-monitoring), surrogate parameters of cellular oxygen tension and consumption (COMET). Analysis of the acute and post-acute course of sepsis (all patients and stratified by the presence of septic cardiomyopathy) to explore potential surrogate parameters for the occurence of cardiac dysfunction. Analysis of potential group differences between septic patients (all patients and stratified by the presence of septic cardiomyopathy) in the acute and post-acute course and control groups (healthy subjects / patients with dilated cardiomyopathy) to identify potential diagnostic parameters. Analysis of the medium- and long-term course of sepsis (all patients and stratified by the presence of septic cardiomyopathy) to assess the reversibility of organ dysfunction, especially cardiovascular dysfunction. Analysis of potential group differences between septic patients (all patients and stratified by the presence of septic cardiomyopathy) in the medium- and long-term course and control groups (healthy individuals / patients with dilated cardiomyopathy) to identify potential biomarkers to predict the medium- and long-term course of sepsis. In this context, potential therapeutic aims will be identified and analysed pre-clinically. Analysis of medium- and long-term morbidity in septic patients (all patients and stratified by the presence of septic cardiomyopathy) by means of physical performance, quality	—

Measure

Time frame

- Difference in mortality rates between septic patients with or without septic cardiomyopathy twelve months after sepsis diagnosis Estimation of incidence of septic cardiomyopathy in the acute phase of sepsis To address further research questions, the parameters from the following methods will be analysed: cardiovascular risk-factors and function (echocardiography), body composition (especially extracellular body water, bioelectrical impedance analysis), organ dysfunctions, immune-status, metabolome, lipidome, microbiome, function of the autonomic nervous system (Holter-monitoring), surrogate parameters of cellular oxygen tension and consumption (COMET). Analysis of the acute and post-acute course of sepsis (all patients and stratified by the presence of septic cardiomyopathy) to explore potential surrogate parameters for the occurence of cardiac dysfunction. Analysis of potential group differences between septic patients (all patients and stratified by the presence of septic cardiomyopathy) in the acute and post-acute course and control groups (healthy subjects / patients with dilated cardiomyopathy) to identify potential diagnostic parameters. Analysis of the medium- and long-term course of sepsis (all patients and stratified by the presence of septic cardiomyopathy) to assess the reversibility of organ dysfunction, especially cardiovascular dysfunction. Analysis of potential group differences between septic patients (all patients and stratified by the presence of septic cardiomyopathy) in the medium- and long-term course and control groups (healthy individuals / patients with dilated cardiomyopathy) to identify potential biomarkers to predict the medium- and long-term course of sepsis. In this context, potential therapeutic aims will be identified and analysed pre-clinically. Analysis of medium- and long-term morbidity in septic patients (all patients and stratified by the presence of septic cardiomyopathy) by means of physical performance, quality

—

Countries

Germany

Contacts

Public ContactPhilipp Baumbach

NWG Translational Septomics, ZIK Septomics, Universitätsklinikum Jena

philipp.baumbach@med.uni-jena.de+4936419325798

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 18, 2026