cfDNA as biomarker for sepsis and acute kidney injury in patients with an acute infection

cfDNA as biomarker for sepsis and acute kidney injury in patients with an acute infection - SeKicfDNA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032819

Enrollment

1629

Registered

2024-05-23

Start date

2023-11-24

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

Interventions

Group 1: Patients with suspicion for sepsis: Patients who present to the rescue center with clinical suspicion of acute, severe infection/sepsis have an additional 21.5 ml of blood taken as part of ro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -presentation in an emergency room, inpatient stay at the Charité – Universitätsmedizin Berlin -ability to consent

Exclusion criteria

Exclusion criteria: -inclusion into this same trial is not possible for a second time -sepsis as diagnosis has already been made

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
• PPV (positive predictive value), NPV (negative predictive value), precision • hours since the beginning of symptoms of severe infection in association with a special composition of cfDNA • days at hospital (kind of ward) and the composition of cfDNA o death, o letality within the study population, 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) o Creatinine at discharge o GFR at discharge o Proteinuria/creatinine in urine, albuminuria/creatinine in urine at admission and discharge, if applicable o information, if dialysis is necessary at discharge o information, if dialysis is necessary during intensive care o CrP, leukocytes and PCT, if applicable, at discharge • presence of bacteria in blood culture and the association with the certain composition of cfDNA • which bacteria species and the association with composition of cfDNA	—

Measure

Time frame

• PPV (positive predictive value), NPV (negative predictive value), precision • hours since the beginning of symptoms of severe infection in association with a special composition of cfDNA • days at hospital (kind of ward) and the composition of cfDNA o death, o letality within the study population, 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) o Creatinine at discharge o GFR at discharge o Proteinuria/creatinine in urine, albuminuria/creatinine in urine at admission and discharge, if applicable o information, if dialysis is necessary at discharge o information, if dialysis is necessary during intensive care o CrP, leukocytes and PCT, if applicable, at discharge • presence of bacteria in blood culture and the association with the certain composition of cfDNA • which bacteria species and the association with composition of cfDNA

—

Countries

Austria, Germany

Contacts

Public ContactWiebke Düttmann-Rehnolt

Charité - Universitätsmedizin Berlin

wiebke.duettmann@charite.de030-450-614204

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026