Extracorporeal Immune Support System (EISS) for the Treat... | NCT00818597

Studies
Extracorporeal Immune Support System (EISS) for the Treatment of Septic Patients

NCT00818597

Sponsor

University of Rostock

Status

Completed

Last Update Posted

Jan 7, 2009Estimated

Enrollment

10Actual

Phase

Phase 1Phase 2

Conditions

Severe Sepsis and Septic Shock

Interventions

EISS

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

Jan 2009

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

Dec 2003

Primary Completion Date

Apr 2004Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jan 5, 2009

First Submission Date that Met QC Criteria

Jan 6, 2009

First Posted Date

Jan 7, 2009Estimated

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

Jan 6, 2009

Last Update Posted Date

Jan 7, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to investigate the effect of an extracorporeal application of a bed-side bioreactor containing human donor granulocytes on the course and outcome of septic shock in humans.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EISS-treatment	Experimental	In this arm patients receive additional treatment with the EISS-bioreactor	Device: EISS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EISS	Device	Two six hour-treatments with the EISS-Immune-cell bioreactor device within 72 hours post inclusion.	EISS-treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
single organ functions (circulation, kidney, lung, liver)		28day post inclusion

Secondary Outcomes

Measure	Description	Time Frame
survival		28day post inclusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

sepsis with at least one organ failure (severe sepsis) or septic shock

Exclusion Criteria:

Participation in another study within the last 30 days
Earlier participation in this study
Pregnancy
Bleeding, clinically not controlled (needing more than 2 red blood cell-transfusions per day)
Hemodynamic shock for more than 12 hours (systolic BP <90mmHg) despite adequate therapy
HIV infection
HCV infection, active

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rostock, Department of Medicine, Division of Nephrology		Rostock		18055	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11778929	Background	Mitzner SR, Freytag J, Sauer M, Kleinfeldt T, Altrichter J, Klohr S, Koball S, Stange J, Ringel B, Nebe B, Schmidt H, Podbielski A, Noeldge-Schomburg G, Schmidt R. Use of human preconditioned phagocytes for extracorporeal immune support: introduction of a concept. Ther Apher. 2001 Oct;5(5):423-32. doi: 10.1046/j.1526-0968.2001.00378.x.
19114920

ID	Term
D018805	Sepsis
D012772	Shock, Septic

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes