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

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02961166
• Collaborator: Universität Tübingen (Other)
• Enrollment: 57
• Location: 1
• Duration (Months): 52
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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	Phase
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.

Study Design

• 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: Jan 1, 2012
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	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 Names: Pentaglobin, Biotest Pharma GmbH Germany; Code 170a/90
Control ARDS patients with septic shock requiring ECMO therapy were NOT treated by IgM-enriched Immunoglobulin

Outcome Measures

Primary Outcome Measures

1. Mortality [during ICU treatment, up to 28 days]

   Death during ICU therapy

Secondary Outcome Measures

1. lengh of stay (LOS ICU) [up to 60 days]

   lengh of stay on ICU in days

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All data available

• ARDS with ECMO therapy

Exclusion Criteria:

• Data missing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Tuebingen	Tuebingen		Germany	72076

Sponsors and Collaborators

• University Hospital Tuebingen
• Universität Tübingen

Investigators

• Principal Investigator: Helene A Haeberle, MD, University Hospital Tuebingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Nov 10, 2016
• Last Update Posted: Apr 24, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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, PD Dr. med. Helene Haeberle, University Hospital Tuebingen: IVIG; ARDS; ECMO
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies

Study Results

No Results Posted as of Apr 24, 2018