Identification of cardiovascular and molecular prognostic factors for the morbidity and mortality in COVID-19-sepsis

Not Applicable

• Conditions: A41.9; J10; U07.1; Sepsis, unspecified; Influenza due to identified seasonal influenza virus; COVID-19, virus identified

• Registration Number: DRKS00024162
• Lead Sponsor: Translational SeptomicsKlinik für Anästhesiologie und IntensivmedizinUniversitätsklinikum Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-09
• Study Completion: 2023-07-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

written informed consent of the patient or his legal representative

- confirmed SARS-CoV-2 infection OR confirmed influenza virus infection.

- respiratory symptoms

- indication for ICU-therapy

- sepsis or septic shock according to Sepsis-3 criteria

- first infection-associated organ dysfunction (= sepsis diagnosis) no older than 4 days (first blood sample within 4 days after sepsis diagnosis)

Exclusion Criteria

• cardiac surgery = 12 months

• significant pre-existing heart condition
o endocarditis
o higher-grade valvular heart disease
o (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
o (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 before sepsis begin

• 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in mortality rates between COVID-19-sepsis patients with vs. without septic cardiomyopathy 3 months after diagnosis of COVID-19-sepsis (T5)