- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00197886
Dose of Norepinephrine and the Concentration of L-Lactate in the Rectum and Stomach in Patients With Septic Shock.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Herlev, Denmark, 2730
- Dept. of Intensive Care, Herlev University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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L-lactate concentration in the rectum and stomach.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Anders Perner, MD,PhD, Dept. of Anaesthesia and Intensive Care, Herlev University Hospital, DK-2730 Herlev
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Shock
- Sepsis
- Shock, Septic
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Norepinephrine
Other Study ID Numbers
- 2004-7041-20
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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