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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:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00197886
First received: September 14, 2005
Last updated: September 19, 2006
Last verified: September 2006
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Shock
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00197886     History of Changes
Other Study ID Numbers: 2004-7041-20
Study First Received: September 14, 2005
Last Updated: September 19, 2006
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on October 16, 2012