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Completed

NCT Number: NCT02961166

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

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.

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Key information

Conditions

Respiratory Distress Syndrome, Adult Infections Inflammation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Tuebingen

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All data available
  • ARDS with ECMO therapy

Exclusion criteria

  • Data missing

Treatment and study plan

IgM enriched Immunoglobulins

Drug

Treatment for 3 days

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

Primary outcomes

  1. Mortality

    Time frame: during ICU treatment, up to 28 days

    Death during ICU therapy

Secondary outcomes

  1. lengh of stay (LOS ICU)

    Time frame: up to 60 days

    lengh of stay on ICU in days

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Universität Tübingen

Registry information

Official study title

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

Acronym: IVIG

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 10, 2016
Registry last updated
Apr 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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