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

Completed

• Conditions: Sepsis

• Registration Number: NCT02444871
• Lead Sponsor: Goethe University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2015-05
• Study First Submitted: 2015-05-09
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-15
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in endotoxin activity	Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours	The endotoxin activity of the patients was measured with a point of care assay and noted in on an arbitrary scale from 0 to 1.0

Secondary Outcome Measures

Name	Time	Method
Changes in CT-NATEM	Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours	Changes in clotting time (CT) of the naturally activated rotational thrombelastometry (ROTEM), results were noted in seconds.
Changes in MCF-NATEM	Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours	Changes in maximum clot firmness (MCF) of the naturally activated rotational thrombelastometry (ROTEM), results were noted in millimeters.
Changes in CFT-NATEM	Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours	Changes in clot formation time (CFT) of the naturally activated rotational thrombelastometry (ROTEM), results were noted in seconds.
Changes in NATEM-Alpha angle	Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours	Changes in Alpha angle of the naturally activated rotational thrombelastometry (ROTEM), results were noted in °.
Changes in ADPtest	Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours	Platelet activation was measured as the area under the curve of a multiple electrode aggregometry. Platelets were activated using adenosine diphosphate (ADPtest)
Changes in ASPItest	Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours	Platelet activation was measured as the area under the curve of a multiple electrode aggregometry. Platelets were activated using arachidonic acid (ASPItest)
Changes in TRAPtest	Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours	Platelet activation was measured as the area under the curve of a multiple electrode aggregometry. Platelets were activated using thrombin receptor activating peptide (TRAPtest)
Platelet count	Baseline, 12, 24, 36, 48, 60, 72 and 84 hours	Platelet count was determined in the clinical routine and noted /nl.
Interleukin-6	Baseline, 12, 24, 36, 48, 60, 72 and 84 hours	Interleukin-6 level was determined in the clinical routine and was noted in pg/ml.
Leukocyte count	Baseline, 12, 24, 36, 48, 60, 72 and 84 hours	Leukocyte count was determined in the clinical routine and was noted /µl.
Lipopolysaccharide-binding-protein (LBP)	Baseline, 24, 48 and 72 hours	Lipopolysaccharide-binding-protein (LBP) was determined in the clinical routine and was noted in µg/l.

Trial Locations

Locations (1)

Johann Wolfgang Goethe-University; 🇩🇪 Frankfurt, Hessen, Germany