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CompletedNCT02961166IVIGUpdated Apr 24, 2018

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

An observational study in Respiratory Distress Syndrome, Adult and Septic Shock, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2018-04-24.

Sponsored by University Hospital Tuebingen · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
57
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Respiratory Distress Syndrome, Adult
  • Septic Shock

Keywords

  • IVIG
  • ARDS
  • ECMO
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 57 is below the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Inclusion criteria

  • All data available
  • ARDS with ECMO therapy

Exclusion criteria

Exclusion Criteria:

  • Data missing
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
57 participants (actual)
Patient registry
No

Groups and cohorts

  • IgM enriched Immunoglobulins

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

    Drug: IgM enriched Immunoglobulins

  • Control

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

Interventions

  • DrugIgM enriched Immunoglobulins

    Treatment for 3 days

    Also known as: Pentaglobin, Biotest Pharma GmbH Germany; Code 170a/90

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What researchers measure

Primary outcomes

  1. Mortality

    Death during ICU therapy

    Time frame: during ICU treatment, up to 28 days

Secondary outcomes

  1. lengh of stay (LOS ICU)

    lengh of stay on ICU in days

    Time frame: up to 60 days

07

Study locations

1 site
  • University Hospital Tuebingen
    Tuebingen, 72076, Germany
08

References and documents

Publications

  • Prohaska S, Schirner A, Bashota A, Korner A, Blumenstock G, Haeberle HA. Intravenous immunoglobulin fails to improve ARDS in patients undergoing ECMO therapy. J Intensive Care. 2018 Feb 26;6:11. doi: 10.1186/s40560-018-0278-8. eCollection 2018. PubMed 29497534 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02961166
Lead sponsor
University Hospital Tuebingen
Collaborators
Universität Tübingen
Responsible party
PD Dr. Helene Haeberle (PD Dr. med. Helene Haeberle, University Hospital Tuebingen) — Principal investigator
First posted
Nov 10, 2016
Start date
Jan 2012
Primary completion
Jan 2016
Completion
May 2016
Last update
Apr 24, 2018

Study contacts

Helene A Haeberle, MD
principal investigator · University Hospital Tuebingen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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