NCT02444871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

6 months

First QC Date

May 9, 2015

Last Update Submit

May 27, 2015

Conditions

Sepsis

Keywords

IgM-enriched immunoglobulinsendotoxin activity assaythrombelastometryaggregometry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Changes in CT-NATEM

    Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours

  • Changes in MCF-NATEM

    Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours

  • Changes in CFT-NATEM

    Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours

  • Changes in NATEM-Alpha angle

    Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours

  • Changes in ADPtest

    Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with severe sepsis or septic shock in a surgical, tertiary care ICU

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johann Wolfgang Goethe-University

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Publications (1)

  • 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.

    PMID: 27504630DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Saskia Wand

Study Record Dates

First Submitted

May 9, 2015

First Posted

May 15, 2015

Study Start

January 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

DE(1)