Incidence of Sepsis-induced Coagulopathy - Trial

Incidence of Sepsis-induced Coagulopathy - Trial - INSIC-Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035249

Enrollment

850

Registered

2024-10-09

Start date

2025-03-10

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

Sepsis and sepsis-induced Koagulopathy

Interventions

Group 1: All adult patients with sepsis and septic shock in intermediate care (IMC) and intensive care (ICU) units.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Sepsis or septic shock Definition of sepsis: Acute suspected or confirmed infection + new increase in SOFA score of = 2 points compared to baseline (last documented value in ICU, or approximated baseline in case of known pre-existing conditions (e.g. renal insufficiency, COPD, thrombopenia, pre-existing brain damage) Definition of septic shock: sepsis + lactate = 2 mmol/L after initial volume bolus of 30 ml/kg bw

Exclusion criteria

Exclusion criteria: < 18 years of age

Design outcomes

Primary

Measure	Time frame
· Point prevalence of sepsis-induced coagulopathy (SIC) on day 1 of the study period and on 3 reference days in the 4th quarter of each year from 2019-2023 · Incidence of SIC within a 14-day observation period (new cases/1,000 ITS days	—

Secondary

Measure	Time frame
· Length of stay in the monitoring area (ICU & IMC) until transfer to a normal ward · ICU mortality (all patients and in the subgroups of patients with sepsis, septic shock, SIC according to the different scores) · 28-day hospital mortality (all patients and in the subgroups of patients with sepsis, septic shock, SIC according to the different scores) · Thromboembolic events after sepsis onset (in sepsis, septic shock and SIC) up to day 28, death or hospital discharge (whichever occurs first Relevant bleeding without surgical trauma (hemoglobin loss >1 point within 24 hours, due to bleeding and not just to dilution) after sepsis onset (in sepsis, septic shock and SIC) until day 28, death or hospital discharge (whichever occurs first)	—

Measure

Time frame

· Length of stay in the monitoring area (ICU & IMC) until transfer to a normal ward · ICU mortality (all patients and in the subgroups of patients with sepsis, septic shock, SIC according to the different scores) · 28-day hospital mortality (all patients and in the subgroups of patients with sepsis, septic shock, SIC according to the different scores) · Thromboembolic events after sepsis onset (in sepsis, septic shock and SIC) up to day 28, death or hospital discharge (whichever occurs first Relevant bleeding without surgical trauma (hemoglobin loss >1 point within 24 hours, due to bleeding and not just to dilution) after sepsis onset (in sepsis, septic shock and SIC) until day 28, death or hospital discharge (whichever occurs first)

—

Countries

Austria, Germany, Luxembourg

Contacts

Public ContactThomas Schmoch

Klinik für Anästhesiologie und Intensivmedizin der Universitätsmedizin Essen

thomas.schmoch@uk-essen.de+49 201 7231401

Outcome results

None listed

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