cfDNA as biomarker for sepsis and acute kidney injury in patients with an acute infectio
Recruiting
- Conditions
- A41Other sepsis
- Registration Number
- DRKS00032819
- Lead Sponsor
- acib GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1629
Inclusion Criteria
presentation in an emergency room, inpatient stay at the Charité – Universitätsmedizin Berlin
-ability to consent
Exclusion Criteria
-inclusion into this same trial is not possible for a second time
-sepsis as diagnosis has already been made
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Performance of cfDNA (cell free Desoxyribonukleid Acid) to recognize patients with an acute infection and incipient dysfunction or a prognosis, evaluated by sensitivity and specificity
- Secondary Outcome Measures
Name Time Method • PPV (positive predictive value), NPV (negative predictive value), precision<br>• hours since the beginning of symptoms of severe infection in association with a special composition of cfDNA<br>• days at hospital (kind of ward) and the composition of cfDNA <br>o death,<br>o letality within the study population, <br>o morbidity evaluated by Clinical Frailty Scale at admission and discharge (https://www.divi.de/images/Dokumente/200331_DGG_Plakat_A4_Clinical_Frailty_Scale_CFS.pdf) <br>o Creatinine at discharge<br>o GFR at discharge<br>o Proteinuria/creatinine in urine, albuminuria/creatinine in urine at admission and discharge, if applicable<br>o information, if dialysis is necessary at discharge<br>o information, if dialysis is necessary during intensive care <br>o CrP, leukocytes and PCT, if applicable, at discharge<br>• presence of bacteria in blood culture and the association with the certain composition of cfDNA <br>• which bacteria species and the association with composition of cfDNA