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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immunoglobulin-M-enriched (IgM-enriched) Immunoglobulin Attenuates Systemic Endotoxin Activity in Early Severe Sepsis

Conditions
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Sepsis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in endotoxin activity | 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 | Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IgM-enriched immunoglobulins, endotoxin activity assay, thrombelastometry, aggregometry