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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02961166
Recruitment Status : Completed
First Posted : November 10, 2016
Last Update Posted : April 24, 2018
Sponsor:
Collaborator:
Universität Tübingen
Information provided by (Responsible Party):
PD Dr. Helene Haeberle, University Hospital Tuebingen

Brief 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.


Condition or disease Intervention/treatment
Respiratory Distress Syndrome, Adult Septic Shock Drug: IgM enriched Immunoglobulins

Detailed 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.

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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Intravenous Immunoglobulin Therapy in ARDS Patients With Extracorporeal Membrane Oxygenation (ECMO) Therapy
Study Start Date : January 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : May 2016


Group/Cohort Intervention/treatment
IgM enriched Immunoglobulins
ARDS patients with septic shock requiring ECMO therapy were treated for 3 days by IgM-enriched Immunoglobulin
Drug: IgM enriched Immunoglobulins
Treatment for 3 days
Other Name: Pentaglobin, Biotest Pharma GmbH Germany; Code 170a/90

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



Primary Outcome Measures :
  1. Mortality [ Time Frame: during ICU treatment, up to 28 days ]
    Death during ICU therapy


Secondary Outcome Measures :
  1. lengh of stay (LOS ICU) [ Time Frame: up to 60 days ]
    lengh of stay on ICU in days



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ARDS patients treated by ECMO in the anesthesiological ICU of University Hospital Tuebingen between january 2012 and december 2015
Criteria

Inclusion Criteria:

  • All data available
  • ARDS with ECMO therapy

Exclusion Criteria:

  • Data missing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961166


Locations
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Germany
University Hospital Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Universität Tübingen
Investigators
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Principal Investigator: Helene A Haeberle, MD University Hospital Tuebingen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PD Dr. Helene Haeberle, PD Dr. med. Helene Haeberle, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02961166    
Other Study ID Numbers: University Hospital Tuebingen
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PD Dr. Helene Haeberle, University Hospital Tuebingen:
IVIG
ARDS
ECMO
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs