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

This study has been completed.

First Received: September 14, 2005 Last Updated: September 19, 2006 History of Changes

Sponsored by:	Herlev Hospital
Information provided by:	Herlev Hospital
ClinicalTrials.gov Identifier:	NCT00197886

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:	Treatment, Randomized, Single Blind, Uncontrolled, Crossover Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Drug Information available for: Norepinephrine Norepinephrine bitartrate

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

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

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Cardiovascular Agents
Adrenergic Agonists
Inflammation

Sepsis
Shock
Shock, Septic
Norepinephrine
Vasoconstrictor Agents
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Physiological Effects of Drugs
Cardiovascular Agents
Infection
Pharmacologic Actions
Adrenergic Agonists

Inflammation
Sepsis
Pathologic Processes
Shock
Autonomic Agents
Therapeutic Uses
Shock, Septic
Norepinephrine
Vasoconstrictor Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 03, 2009