Immunglobulin M Enriched Intra Venous Immunoglobulin (IVI... | NCT02961166

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

NCT02961166

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Apr 24, 2018Actual

Enrollment

57Actual

Phase

Not provided

Conditions

Respiratory Distress Syndrome, Adult
Septic Shock

Interventions

IgM enriched Immunoglobulins

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jan 2016Actual

Completion Date

May 2016Actual

First Submitted Date

May 8, 2016

First Submission Date that Met QC Criteria

Nov 8, 2016

First Posted Date

Nov 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2018

Last Update Posted Date

Apr 24, 2018Actual

Name	Class
Universität Tübingen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
IgM enriched Immunoglobulins	Drug	Treatment for 3 days	IgM enriched Immunoglobulins

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Death during ICU therapy	during ICU treatment, up to 28 days

Secondary Outcomes

Measure	Description	Time Frame
lengh of stay (LOS ICU)	lengh of stay on ICU in days	up to 60 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All data available
ARDS with ECMO therapy

Exclusion Criteria:

Data missing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

ARDS patients treated by ECMO in the anesthesiological ICU of University Hospital Tuebingen between january 2012 and december 2015

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helene A Haeberle, MD	University Hospital Tuebingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Tuebingen		Tübingen		72076	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29497534	Derived	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.

ID	Term
D012128	Respiratory Distress Syndrome
D012772	Shock, Septic

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D018805	Sepsis