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

• Conditions: A41.9; Sepsis, unspecified

• Registration Number: DRKS00013347
• Lead Sponsor: WG Translational Septomics, Zentrum für Innovationskomepetenz (ZIK) Septomics, Universitätklinikum Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-30
• Study Completion: 2022-06-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 302

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in mortality rates between septic patients with and without septic cardiomyopathy six months after sepsis diagnosis<br><br>