Back to resultsDose of Norepinephrine and the Concentration of L-Lactate in the Rectum and Stomach in Patients With Septic Shock.
Primary Purpose
Septic Shock
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Changing dose of norepinephrine and blood pressure
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock
Eligibility Criteria
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
Sites / Locations
- Dept. of Intensive Care, Herlev University Hospital
Outcomes
Primary Outcome Measures
L-lactate concentration in the rectum and stomach.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00197886
Brief Title
Dose of Norepinephrine and the Concentration of L-Lactate in the Rectum and Stomach in Patients With Septic Shock.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Herlev Hospital
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Changing dose of norepinephrine and blood pressure
Primary Outcome Measure Information:
Title
L-lactate concentration in the rectum and stomach.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Perner, MD,PhD
Organizational Affiliation
Dept. of Anaesthesia and Intensive Care, Herlev University Hospital, DK-2730 Herlev
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. of Intensive Care, Herlev University Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Dose of Norepinephrine and the Concentration of L-Lactate in the Rectum and Stomach in Patients With Septic Shock.
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