Lactic Acid in the Rectum and Life-Threatening Infection | NCT00197938

Studies
Lactic Acid in the Rectum and Life-Threatening Infection

NCT00197938

Sponsor

Herlev Hospital

Status

Completed

Last Update Posted

Jun 9, 2009Estimated

Enrollment

130Actual

Phase

Not provided

Conditions

Septic Shock

Interventions

Measurement of rectal lactic acid.

Countries

Denmark
Finland

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Not provided

Completion Date

Apr 2009Actual

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 20, 2005Estimated

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 5, 2009

Last Update Posted Date

Jun 9, 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 lactic acid.

The investigators hypothesize, that the more serious the condition, the higher the concentration of lactic acid will be, thus relating to the risk of multiple organ failure or death.

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

130Actual

Name	Type	Description	Arm Group Labels	Other Names
Measurement of rectal lactic acid.	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fluid resuscitated septic shock < 24 h.

Exclusion Criteria:

Septic shock > 24 h.
Pathology in the rectum.
Bleeding per rectum.
Limitation of therapy.
Where informed consent from relatives cannot be obtained.

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

Adult patients with early septic shock (< 24 h).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anders Perner, MD, PhD	Dept. of Anaesthesia and Intensive Care, Herlev University Hospital, DK-2730 Herlev	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Intensive Care 4131, Rigshospitalet		Copenhagen		DK-2100	Denmark
Dept. of Intensive Care, Glostrup University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20560883	Derived	Ibsen M, Tenhunen J, Wiis J, Waldau T, Lauritsen AO, Thornberg K, Joensen H, Perner A. Lactate concentrations in the rectal lumen in patients in early septic shock. Acta Anaesthesiol Scand. 2010 Aug;54(7):827-32. doi: 10.1111/j.1399-6576.2010.02263.x. Epub 2010 Jun 15.

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