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Functional Epigenomics of Sepsis

Functional Epigenomics of Sepsis - FUEGOS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00018867
Enrollment
250
Registered
2019-11-15
Start date
2019-11-15
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 A40

Interventions

Group 1: Patients with Sepsis Group 2: Patients before and after large surgery Group 3: Healthy probands

Sponsors

Klinik für AnästhesiologieUniversitätsklinikum Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with Sepsis: Consent by the legal representative; At least 2 SIRS criteria met: - temperature 38ºC - tachycardia (> 90 /min) - leukocytosis (> 12,000 /µl) OR leukopenia (10% immature blasts) - Tachypnea (> 20 /min) OR paCO2 <32 mmHg OR oxygenation index (FiO2/paO2) <200 OR mechanical Ventilation; Clinical or microbiological evidence of infection Sepsis-associated organ dysfunction indicated by a change in the Sequential Organ Failure Assessment (SOFA) score by 2 or more points (compared to previous day) Patients after surgery: Informed consent; Elective major surgery scheduled. Healthy volunteers: Informed consent.

Exclusion criteria

Exclusion criteria: Common exclusion criteria of all study groups: Pregnancy; Inclusion in an interventional study; infectious viral diseases (HBV, HCV, HIV); Iatrogenic immunosuppression. Specific exclusion criteria of patients with sepsis: Diagnosis "sepsis" >24 h. Specific exclusion criteria of healthy volunteers: One of the following states during the last 7 days: - Influenza infection or flu - Sports injuries or other trauma - Large-scale dental interventions (e.g., tooth extraction) - Blood or platelet donation.

Design outcomes

Primary

MeasureTime frame
Measurement of the distribution of genome-wide histone modifications in isolated peripheral blood mononuclear cells (PBMCs) using chromatin immunoprecipitation sequencing

Secondary

MeasureTime frame
Measurement of global gene expression in isolated PBMCs using RNA-Seq, validated by qPCR Measurement of global DNA methylation in isolated PBMCs using microarray Measurement of metabolic pathways in isolated PBMCs using Seahorse™ Technology Measurement of phagocytic activity of immune cells using FACS Measurement of PBMCs functional competence for cytokine release by stimulation and ELISA phenotyping of immune cell populations using FACS Quantification of chemokines, cytokines, and metabolic metabolites in plasma by ELISA, or mass spectrometry Composition of the gastrointestinal microbiome using 16S sequencing Occurrence of secondary infections 28-day survival stay in hospital and intensive care unit

Countries

Germany

Contacts

Public ContactMarkus A. Weigand

Klinik für AnästhesiologieUniversitätsklinikum Heidelberg

markus.weigand@med.uni-heidelberg.de+49 6221 56-6350

Outcome results

None listed

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