Clinical trial NCT02444871: IgM-enriched Immunoglobulin Attenuates Systemic Endotoxin Activity in Early Severe Sepsis
Official title: Immunoglobulin-M-enriched (IgM-enriched) Immunoglobulin Attenuates Systemic Endotoxin Activity in Early Severe Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: IgM-enriched immunoglobulins
endotoxin activity assay
thrombelastometry
aggregometry
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe sepsis or septic shock in a surgical, tertiary care ICU

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in endotoxin activity
timeFrame: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
Secondary outcomes:
measure: Changes in CT-NATEM
timeFrame: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
measure: Changes in MCF-NATEM
timeFrame: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
measure: Changes in CFT-NATEM
timeFrame: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
measure: Changes in NATEM-Alpha angle
timeFrame: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
measure: Changes in ADPtest
timeFrame: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
measure: Changes in ASPItest
timeFrame: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
measure: Changes in TRAPtest
timeFrame: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
measure: Platelet count
timeFrame: Baseline, 12, 24, 36, 48, 60, 72 and 84 hours
measure: Interleukin-6
timeFrame: Baseline, 12, 24, 36, 48, 60, 72 and 84 hours
measure: Leukocyte count
timeFrame: Baseline, 12, 24, 36, 48, 60, 72 and 84 hours
measure: Lipopolysaccharide-binding-protein (LBP)
timeFrame: Baseline, 24, 48 and 72 hours
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe-University
state: Hessen
Study officials:
References:
citation: 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.