Cellfree DNA as a prognostic biomarker in ICU patients suffering from COVID-19 or sepsis

• Conditions: COVID-19, sepsis; A41.9; Sepsis, unspecified

• Registration Number: DRKS00025222
• Lead Sponsor: Klinik für Anästhesiologie der Universitätsmedizin Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-30
• Study Completion: 2022-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Patients who meet the following criteria will be included in this study:
-Patients =18 years of age with one of the three following diagnoses:
- Acute SARS-Cov-2 infection upon admission to the intensive care unit OR
- Sepsis with no known previous SARS-CoV-2 infection

Exclusion Criteria

Patients who meet only one of the following criteria will not be included in this study:
- Pregnant women
- Breastfeeding women
- Known, active tumor disease in treatment
- Palliative therapy approach
- Present DNR (Do Not Resuscitate) / DNI (Do Not Intubate) / DNARRT (Do Not Apply Renal Replacement Therapy) arrangement
- Inclusion stop at escalation level 4 according to SOP of the COVID supply

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the overall survival of the patients in both groups (COVID-19 group, sepsis group) within the first 30 days after determining the first cfDNA value.

Secondary Outcome Measures

Name	Time	Method
Secondary objectives are<br>- Cf-DNA course in the following subgroups: COVID group, sepsis group, survivors, deceased. The course parameters to be examined are maximum, minimum, average, difference between maximum and minimum, falling or rising trend of the three recorded values.<br>- Association of cf-DNA maximum and other course parameters with<br>a) Risk factors (age, frailty, diabetes, obesity, hypertension, immunodeficiency)<br>b) Organ failure (SOFA total and partial scores)<br>c) Inflammation (white blood cell count, CRP, interleukin-6)<br>d) Coagulopathy (D-dimers, platelet count)<br>e) Complications (neurological, pulmonary, cardiac, renal)<br>f) Outcome (ventilation-free days, ICU days, length of hospital stay)<br>- Comparison of these associations between COVID and sepsis groups