IgM-enriched Immunoglobulin Attenuates Systemic Endotoxin Activity in Early Severe Sepsis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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age >18 years
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proven or suspected severe sepsis or septic shock
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written consent of the patient or a legal person in charge
Exclusion Criteria:
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Pregnancy
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anticoagulation other than heparin
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Inherited coagulopathy or thrombophilia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johann Wolfgang Goethe-University | Frankfurt | Hessen | Germany | 60590 |
Sponsors and Collaborators
- Goethe University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DEEP Trial