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

NCT ID: NCT02444871

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-07-31

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.

Conditions

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Sepsis

Study Design

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Study Time Perspective

PROSPECTIVE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Goethe University

OTHER

Sponsor Role lead

Responsible Party

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Saskia Wand

Dr. Saskia Wand

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Johann Wolfgang Goethe-University

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

References

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Wand S, Klages M, Kirbach C, Warszawska J, Meybohm P, Zacharowski K, Koch A. IgM-Enriched Immunoglobulin Attenuates Systemic Endotoxin Activity in Early Severe Sepsis: A Before-After Cohort Study. PLoS One. 2016 Aug 9;11(8):e0160907. doi: 10.1371/journal.pone.0160907. eCollection 2016.

Reference Type DERIVED
PMID: 27504630 (View on PubMed)

Other Identifiers

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DEEP Trial

Identifier Type: -

Identifier Source: org_study_id

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