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SPLEEN-OFF (Sple[e]nectomy, overwhelming infection and pneumococcal immunity – a nationwide cohort study and case finding study)

SPLEEN-OFF (Sple[e]nectomy, overwhelming infection and pneumococcal immunity – a nationwide cohort study and case finding study) - SPLEEN-OFF

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00000417
Enrollment
200
Registered
2011-02-24
Start date
2011-11-01
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

OPS 5-413 A41 D73.0 Q89.0

Interventions

Group 1: patients with asplenia and sepsis Group 2: patients without asplenia and sepsis

Sponsors

Zentrum für chronische Immundefizienz Freiburg (CCI)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Cases key inclusion criteria: - Community-acquired severe sepsis/septic shock - Sepsis start = 48 h prior hospitalization - History of splenectomy or proof of spenectomie through ultrasound or CT-scan - age = 18 years Controls key inclusion criteria: - Consecutive admission at the same Intensive Care Unit with community-acquired severe sepsis/septic shock - Sepsis start = 48 h prior hospitalization - No history of splenectomy or proof of existing spleen through ultrasound or CT-scan - age = 18 years - Similar age and same sex as case

Exclusion criteria

Exclusion criteria: missing informed consent

Design outcomes

Primary

MeasureTime frame
Proportion of patients with OPSI due to S. pneumoniae compared to age and sex-matched cases with community-acquired severe sepsis/septic shock without splenectomy (comparison group) Determination through blood culture and pcr for pneumocoocus at study entry

Secondary

MeasureTime frame
Comparison cases versus controls (APACHE II Score , SOFA Score day 0, 1, 3, 3 and 7) Distribution of foci, distribution of pathogens apart from pneumococci 28-day mortality, and sepsis severity (days of ventilation an dialysis, days of admission to ICU and hospital) Charlson Comorbidity index, prognostic factors (indication for splenectomy, Underlying disease/comorbidity, immunosuppression and vaccination status etc)

Countries

Germany

Contacts

Public ContactChristian Theilacker

CCI Zentrum für Infektiologie und Reisemedizin

christian.theilacker@gmail.com+49 761 270 18190

Outcome results

None listed

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