Immunglobulin M Enriched Intra Venous Immunoglobulin (IVIG) Therapy in Adult Respiratory Distress Syndrom (ARDS) Patients

NCT ID: NCT02961166

Last Updated: 2018-04-24

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

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-05-31

Brief Summary

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57 patients with Adult Respiratory Distress Syndrome (ARDS) requiring Extracorporeal membrane oxygenation (ECMO) therapy were analyzed retrospectively. 28 patients had received immunglobulin M-enriched immunoglobulin therapy (IVIG); 29 patients did not receive IVIG therapy.

These patients were analyzed regarding length of stay in intensive care unit (LOS ICU), length of stay (LOS) in hospital and regarding mortality.

Detailed Description

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57 patients with ARDS requiring ECMO therapy were analyzed retrospectively. 28 patients had received IgM-enriched immunoglobulin therapy (IVIG); 29 patients did not receive IVIG therapy.

Patient characteristics, like Acute Physiology And Chronic Health Evaluation (APACHE) and Sepsis-related organ failure assessment (SAPS) Score, preexisting diseases, origin of infection, duration of ECMO therapy were analyzed in these patients.

These patients were further analyzed regarding LOS ICU, LOS in hospital and regarding mortality.

Conditions

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Respiratory Distress Syndrome, Adult Septic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IgM enriched Immunoglobulins

ARDS patients with septic shock requiring ECMO therapy were treated for 3 days by IgM-enriched Immunoglobulin

IgM enriched Immunoglobulins

Intervention Type DRUG

Treatment for 3 days

Control

ARDS patients with septic shock requiring ECMO therapy were NOT treated by IgM-enriched Immunoglobulin

No interventions assigned to this group

Interventions

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IgM enriched Immunoglobulins

Treatment for 3 days

Intervention Type DRUG

Other Intervention Names

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Pentaglobin, Biotest Pharma GmbH Germany; Code 170a/90

Eligibility Criteria

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Inclusion Criteria

* All data available
* ARDS with ECMO therapy

Exclusion Criteria

* Data missing
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universität Tübingen

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. Helene Haeberle

PD Dr. med. Helene Haeberle

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helene A Haeberle, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

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University Hospital Tuebingen

Tübingen, , Germany

Site Status

Countries

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Germany

References

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Prohaska S, Schirner A, Bashota A, Korner A, Blumenstock G, Haeberle HA. Intravenous immunoglobulin fails to improve ARDS in patients undergoing ECMO therapy. J Intensive Care. 2018 Feb 26;6:11. doi: 10.1186/s40560-018-0278-8. eCollection 2018.

Reference Type DERIVED
PMID: 29497534 (View on PubMed)

Other Identifiers

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University Hospital Tuebingen

Identifier Type: -

Identifier Source: org_study_id

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