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NCT02961166 Clinical Trial

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

Septic Shock Clinical Trial

— IVIG  

Official title:
Intravenous Immunoglobulin Therapy in ARDS Patients With Extracorporeal Membrane Oxygenation (ECMO) Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02961166
Other study ID # University Hospital Tuebingen
Secondary ID
Status Completed
Phase
First received May 8, 2016
Last updated April 20, 2018
Start date January 2012
Est. completion date May 2016

Study information
Verified date April 2018
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date May 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- All data available

- ARDS with ECMO therapy

Exclusion Criteria:

- Data missing

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• IgM enriched Immunoglobulins
Treatment for 3 days

Locations
Country Name City State
Germany University Hospital Tuebingen Tuebingen

Sponsors (2)
Lead Sponsor Collaborator
University Hospital Tuebingen Universität Tübingen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Death during ICU therapy during ICU treatment, up to 28 days
Secondary lengh of stay (LOS ICU) lengh of stay on ICU in days up to 60 days
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