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Dose of Norepinephrine and the Concentration of L-Lactate in the Rectum and Stomach in Patients With Septic Shock.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00197886
First Posted: September 20, 2005
Last Update Posted: September 20, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Herlev Hospital
  Purpose

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.


Condition Intervention
Septic Shock Drug: Changing dose of norepinephrine and blood pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • L-lactate concentration in the rectum and stomach.

Estimated Enrollment: 10
Study Start Date: October 2004
Estimated Study Completion Date: December 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197886


Locations
Denmark
Dept. of Intensive Care, Herlev University Hospital
Herlev, Denmark, 2730
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

ClinicalTrials.gov Identifier: NCT00197886     History of Changes
Other Study ID Numbers: 2004-7041-20
First Submitted: September 14, 2005
First Posted: September 20, 2005
Last Update Posted: September 20, 2006
Last Verified: September 2006

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents