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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00197886
Other study ID # 2004-7041-20
Secondary ID
Status Completed
Phase N/A
First received September 14, 2005
Last updated September 19, 2006
Start date October 2004
Est. completion date December 2005

Study information

Verified date September 2006
Source Herlev Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

Norepinephrine is a drug used to increase blood pressure in patients with life-threatening infection. However, norepinephrine may limit the bloodflow to the gut, thereby causing relative lack of oxygen to the cells. This leads to increased formation of lactic acid.

This study examines whether increasing the dose of norepinephrine leads to higher concentrations of lactic acid in the rectum and stomach in patients with life-threatening infection.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Septic shock

- NE-dose > 0.1 microg/kg/min

- CI > 3.0 l/min/m2

Exclusion Criteria:

- Age < 18, unable to obtain informed consent from relatives

- Untreated hypertension

- Pregnancy

- Pathology in the rectum or stomach

- Limitation of therapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Changing dose of norepinephrine and blood pressure


Locations

Country Name City State
Denmark Dept. of Intensive Care, Herlev University Hospital Herlev

Sponsors (1)

Lead Sponsor Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary L-lactate concentration in the rectum and stomach.
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