Barrier Function and Production of Inflammatory Cytokines... | NCT00378586

Studies
Barrier Function and Production of Inflammatory Cytokines in the Rectal Mucosa in Patients With Septic Shock

NCT00378586

Sponsor

Herlev Hospital

Status

Unknown status

Last Update Posted

Jun 23, 2009Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Septic Shock

Interventions

Rectal biopsy
Measurement of inflammatory markers in the rectal mucosa
Measurement of rectal lactic acid

Countries

Denmark

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

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 19, 2006

First Submission Date that Met QC Criteria

Sep 19, 2006

First Posted Date

Sep 20, 2006Estimated

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

Jun 22, 2009

Last Update Posted Date

Jun 23, 2009Estimated

Description Module

Brief Summary

Life-threatening infection impairs bloodflow to the gut, thereby causing less delivery of oxygen. This leads to increased formation of different inflammatory and infectious markers.

The investigators hypothesize, therefore, that there is a significant difference in the concentrations of inflammatory and infectious markers in the rectal mucosa between patients with septic shock and healthy controls.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
Rectal biopsy	Procedure	Rectal biopsy.
Measurement of inflammatory markers in the rectal mucosa	Procedure	IL-6, TNF-alfa.
Measurement of rectal lactic acid	Procedure	Equilibrium dialysis.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Septic shock

Exclusion Criteria:

Age < 18 years
No next of kin
Pathology of the descending or sigmoid colon or rectum
Pregnancy
1st degree relatives with inflammatory bowel disease
Severe coagulopathy

Accepts Healthy Volunteers

Yes

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

Septic shock patients.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Ibsen, MD	Contact	+ 45 45 35 94 18		micibs@dadlnet.dk
Anders Perner, MD, PhD	Contact	+ 45 45 35 41 31		ap@dadlnet.dk

Overall Officials

Name	Affiliation	Role
Michael Ibsen, MD	Dept. of Intensive Care 4131, Rigshospitalet, Copenhagen, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Intensive Care 4131		Copenhagen		DK-2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D012772	Shock, Septic

Ancestor Terms

ID	Term
D018805	Sepsis
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation

Browse Leaves

Not provided

Browse Branches

Not provided