Lactic Acid in the Rectum and Life-Threatening Infection

This study has been completed.

First Received: September 14, 2005 Last Updated: June 5, 2009 History of Changes

Sponsored by:	Herlev Hospital
Information provided by:	Herlev Hospital
ClinicalTrials.gov Identifier:	NCT00197938

Purpose

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.

Condition	Intervention
Septic Shock	Procedure: Measurement of rectal lactic acid.

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Does the Concentration of L-Lactate in the Rectum Correlate With Mortality and Morbidity in Patients With Septic Shock?

Resource links provided by NLM:

Drug Information available for: Lactic acid Ammonium lactate

U.S. FDA Resources

Further study details as provided by Herlev Hospital:

Enrollment:	130
Study Start Date:	November 2005
Study Completion Date:	April 2009

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197938

Locations

Denmark
Dept. of Intensive Care, Herlev University Hospital
Herlev, Denmark, DK-2730
Dept. of Intensive Care, Glostrup University Hospital
Glostrup, Denmark, DK-2600
Dept. of Intensive Care, Gentofte University Hospital
Hellerup, Denmark, DK-2900
Dept. of Intensive Care 4131, Rigshospitalet
Copenhagen, Denmark, DK-2100
Finland
Dept. of Intensive Care, Tampere University Hospital
Tampere, Finland, 33521

Sponsors and Collaborators

Herlev Hospital

Investigators

Study Chair:

Anders Perner, MD, PhD

Dept. of Anaesthesia and Intensive Care, Herlev University Hospital, DK-2730 Herlev

More Information

No publications provided

Study ID Numbers:	KA 05091m
Study First Received:	September 14, 2005
Last Updated:	June 5, 2009
ClinicalTrials.gov Identifier:	NCT00197938 History of Changes
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Sepsis
Shock
Shock, Septic
Inflammation

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Sepsis
Pathologic Processes
Shock

Shock, Septic
Infection
Inflammation

ClinicalTrials.gov processed this record on September 03, 2009