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

Completed

• Conditions: Septic Shock; Respiratory Distress Syndrome, Adult
• Interventions: Drug: IgM enriched Immunoglobulins

• Registration Number: NCT02961166
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2016-01
• Study Completion: 2016-05
• Study First Submitted: 2016-05-08
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-10
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-20
• Last Update Posted: 2018-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• All data available
• ARDS with ECMO therapy

Exclusion Criteria

• Data missing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mortality	during ICU treatment, up to 28 days	Death during ICU therapy

Secondary Outcome Measures

Name	Time	Method
lengh of stay (LOS ICU)	up to 60 days	lengh of stay on ICU in days

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany