Point of care coagulation-diagnostic in human sepsis

Recruiting

Conditions: A41
D65
Other sepsis
Disseminated intravascular coagulation [defibrination syndrome]

Registration Number: DRKS00008090

Lead Sponsor: niversitätsklinikum HeidelbergKlinik für Anästhesiologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Patients with Sepsis/ septic shock:
*Written consent form of study participant or his appointed representative
*Age > 18 years
*sepsis-criteria have to be fulfilled (Berlin definition 2012)
SIRS-patients:
*Written consent form of study participant or his appointed representative
*Age > 18 years
*Undergoing major abdominal surgery (e.g. whipple, hemihepatectomy, etc.)
Healthy-probands
*Written consent form of study participant or his appointed representative
*Age > 18 years
*no acute or chronical inflammatory disease

Exclusion Criteria

*Non-fulfillment of inclusion criteria
*Status post recent cardiac surgery
*Status post recently suffered multiple trauma
*Patient whose therapy program includes tranexamic acid
*Refusal of participation in the study

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Applicability of single parameters of the point of care coagulation diagnostics as early diagnostic markers in context of sepsis, as well as their correlation with established inflammatory markers at the time points onset, 3h, 6h, 12h, 24h, 48h, and 7d (CRP, PCT, IL-6, TNF-a).<br>Evaluation of changes in hemostasis in course of major sepsis and septic shock with the aid of modern point of care coagulation diagnostics at the time points onset, 3h, 6h, 12h, 24h, 48h, and 7d.<br>*Search for a secure and early diagnosis parameter for sepsis associated coagulation dysfunction (DIC). <br>

Secondary Outcome Measures

Name	Time	Method
Correlation of the severity of the coagulation dysfunction (assessment via an established scoring system = DIC score), the severity of disease (SOFA score, APACHE-II score, SAPS score), and the duration of stay in the intensive care unit at the time points onset, 3h, 6h, 12h, 24h, 48h, and 7d.<br>Evaluation of the possible diagnostic time advantage of point of care coagulation diagnostics and the resulting earlier start of therapy.<br>