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Completed

NCT Number: NCT02444871

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

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johann Wolfgang Goethe-University

Frankfurt am Main, Hesse, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in endotoxin activity

    Time frame: 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 outcomes

  1. Changes in CT-NATEM

    Time frame: 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.

  2. Changes in MCF-NATEM

    Time frame: 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.

  3. Changes in CFT-NATEM

    Time frame: 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.

  4. Changes in NATEM-Alpha angle

    Time frame: 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 °.

  5. Changes in ADPtest

    Time frame: 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)

  6. Changes in ASPItest

    Time frame: 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)

  7. Changes in TRAPtest

    Time frame: 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)

  8. Platelet count

    Time frame: Baseline, 12, 24, 36, 48, 60, 72 and 84 hours

    Platelet count was determined in the clinical routine and noted /nl.

  9. Interleukin-6

    Time frame: 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.

  10. Leukocyte count

    Time frame: Baseline, 12, 24, 36, 48, 60, 72 and 84 hours

    Leukocyte count was determined in the clinical routine and was noted /µl.

  11. Lipopolysaccharide-binding-protein (LBP)

    Time frame: Baseline, 24, 48 and 72 hours

    Lipopolysaccharide-binding-protein (LBP) was determined in the clinical routine and was noted in µg/l.

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 15, 2015
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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