SepsisNCT02444871
IgM-enriched Immunoglobulin Attenuates Systemic Endotoxin Activity in Early Severe Sepsis
An observational study of Sepsis, run by Goethe University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe sepsis or septic shock in a surgical, tertiary care ICU
Who may be able to join
- age >18 years
- proven or suspected severe sepsis or septic shock
- written consent of the patient or a legal person in charge
Who cannot join
- Pregnancy
- anticoagulation other than heparin
- Inherited coagulopathy or thrombophilia
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johann Wolfgang Goethe-University
Frankfurt am Main, Hesse, 60590
About this study
Official title: Immunoglobulin-M-enriched (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.
Read the 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.
- Conditions
- Sepsis
- Keywords
- IgM-enriched immunoglobulins, endotoxin activity assay, thrombelastometry, aggregometry
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
Secondary outcomes (11)
Changes in CT-NATEM
Changes in clotting time (CT) of the naturally activated rotational thrombelastometry (ROTEM), results were noted in seconds.
Measured: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
Changes in MCF-NATEM
Changes in maximum clot firmness (MCF) of the naturally activated rotational thrombelastometry (ROTEM), results were noted in millimeters.
Measured: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
Changes in CFT-NATEM
Changes in clot formation time (CFT) of the naturally activated rotational thrombelastometry (ROTEM), results were noted in seconds.
Measured: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
Changes in NATEM-Alpha angle
Changes in Alpha angle of the naturally activated rotational thrombelastometry (ROTEM), results were noted in °.
Measured: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
Changes in ADPtest
Platelet activation was measured as the area under the curve of a multiple electrode aggregometry. Platelets were activated using adenosine diphosphate (ADPtest)
Measured: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
Changes in ASPItest
Platelet activation was measured as the area under the curve of a multiple electrode aggregometry. Platelets were activated using arachidonic acid (ASPItest)
Measured: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
Changes in TRAPtest
Platelet activation was measured as the area under the curve of a multiple electrode aggregometry. Platelets were activated using thrombin receptor activating peptide (TRAPtest)
Measured: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
Platelet count
Platelet count was determined in the clinical routine and noted /nl.
Measured: Baseline, 12, 24, 36, 48, 60, 72 and 84 hours
Interleukin-6
Interleukin-6 level was determined in the clinical routine and was noted in pg/ml.
Measured: Baseline, 12, 24, 36, 48, 60, 72 and 84 hours
Leukocyte count
Leukocyte count was determined in the clinical routine and was noted /µl.
Measured: Baseline, 12, 24, 36, 48, 60, 72 and 84 hours
Lipopolysaccharide-binding-protein (LBP)
Lipopolysaccharide-binding-protein (LBP) was determined in the clinical routine and was noted in µg/l.
Measured: Baseline, 24, 48 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saskia Wand, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444871
- Sponsor's protocol ID
- DEEP Trial
- Status last verified
- May 2015
- First submitted
- 9 May 2015
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27504630
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoglobulin-M-enriched (IgM-enriched) Immunoglobulin Attenuates Systemic Endotoxin Activity in Early Severe Sepsis
- ClinicalTrials.gov ID
- NCT02444871
- Acronym / sponsor ID
- DEEP Trial
- Conditions
- Sepsis
- Keywords
- IgM-enriched immunoglobulins, endotoxin activity assay, thrombelastometry, aggregometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe sepsis or septic shock in a surgical, tertiary care ICU
Key inclusion criteria (3 listed)
- age >18 years
- proven or suspected severe sepsis or septic shock
- written consent of the patient or a legal person in charge
Key exclusion criteria (3 listed)
- Pregnancy
- anticoagulation other than heparin
- Inherited coagulopathy or thrombophilia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
11 secondary outcomes
Changes in CT-NATEM
Time frame: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
Changes in MCF-NATEM
Time frame: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
Changes in CFT-NATEM
Time frame: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
Changes in NATEM-Alpha angle
Time frame: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
Changes in ADPtest
Time frame: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
Changes in ASPItest
Time frame: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
Changes in TRAPtest
Time frame: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours
Platelet count
Time frame: Baseline, 12, 24, 36, 48, 60, 72 and 84 hours
Interleukin-6
Time frame: Baseline, 12, 24, 36, 48, 60, 72 and 84 hours
Leukocyte count
Time frame: Baseline, 12, 24, 36, 48, 60, 72 and 84 hours
Lipopolysaccharide-binding-protein (LBP)
Time frame: Baseline, 24, 48 and 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Derived from this study: PubMed 27504630Wand 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endotoxin activity (time frame: Baseline, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78 and 84 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02444871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.