IgM-enriched Immunoglobulin Attenuates Systemic Endotoxin Activity in Early Severe Sepsis

Goethe University

Status: Completed

Conditions: Sepsis

Study type: Observational

Funder types: Other

Identifiers

NCT02444871

DEEP Trial

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of IgM-enriched immunoglobulins (Pentaglobin) on the endotoxin activity, conventional coagulation parameters, viscoelastic and aggregometric measurements of patients with severe sepsis.

Full description

Before the change of the standard operating procedure (SOP) with the implementation of the application of IgM-enriched immunoglobulins to patients with severe sepsis and septic shock conventional inflammatory and coagulation parameters, viscoelastic and aggregometric measurements as well as the endotoxin activity was measured in 15 patients. After the change of SOP the same parameters were recorded for additional 15 patients.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age >18 years
• proven or suspected severe sepsis or septic shock
• written consent of the patient or a legal person in charge

Exclusion criteria

• Pregnancy
• anticoagulation other than heparin
• Inherited coagulopathy or thrombophilia