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Prevention of Low Blood Pressure in Persons With Tetraplegia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00237770
First Posted: October 12, 2005
Last Update Posted: May 19, 2014
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 (Responsible Party):
VA Office of Research and Development
  Purpose
The aim of this investigation is to determine the blood pressure response to NOS inhibition, with L-NAME, in persons with tetraplegia compared to non-SCI control subjects and to establish if blood pressure can be increased while upright in those with tetraplegia. If blood pressure is increased with NOS inhibition in persons with tetraplegia, this would improve our treatment of the condition of low blood pressure during seated postures in individuals with tetraplegia.

Condition Intervention Phase
Hypotension Spinal Cord Injury Drug: N-Nitro L-arginine-methylester (L-NAME) Procedure: Head-up Tilt maneuver Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Low Blood Pressure in Persons With Tetraplegia

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Systolic Blood Pressure During Head-up Tilt [ Time Frame: Average systolic blood pressure during head-up tilt (45 degrees) comparing active drug (L-NAME: 1.0 and 2.0 mg/kg) to placebo. ]
    Average systolic blood pressure over 45 minutes at 45 degrees of head-up tilt.


Enrollment: 16
Study Start Date: June 2003
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1
Placebo control (normal saline) is employed on a separate visit during procedure.
Drug: N-Nitro L-arginine-methylester (L-NAME)
A non-specific inhibitor of the nitric oxide synthase enzyme.
Procedure: Head-up Tilt maneuver
Participant will be placed onto tilt table and brought to 15 degrees of head up tilt for 60 minutes (intravenous infusion time). After this time, a progressive increase to 45 degrees will be completed with a 10 degree increase every 5 minutes. Participant will remain at 45 degrees for 45 minutes or until symptom onset.

Detailed Description:
Despite disruption of central command of the vasculature during orthostatic maneuvers, individuals with tetraplegia are generally able to be seated in an upright position for long periods of time without developing symptoms of orthostatic intolerance. It must be appreciated however, that orthostatic hypotension may occur unpredictably in persons with chronic tetraplegia. This may result in a range of symptoms due to cerebral hypoperfusion from mild reduction in mental acuity to loss of consciousness. Nitric oxide (NO) is the most potent endogenous vasodilator which is synthesized by the enzyme NO synthase (NOS) and may be largely responsible for orthostatic hypotension in individuals with immobilizing conditions. Recent evidence suggests an up-regulation of inducible nitric oxide synthases (NOS) activity with prolonged exposure to hind limb suspension. The effects of NOS inhibition during orthostasis on blood pressure regulation in those with chronic tetraplegia may provide insight into effective pharmacological therapy to reduce or prevent pathologic orthostatic changes. Treatment with a NOS inhibitor may facilitate the process of mobilization in those with acute higher cord lesions.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 to 65 year olds.
  • Non-ambulatory Chronic tetraplegia (1 year after acute SCI).

Exclusion Criteria:

  • central nervous system disease (other than SCI) e.g., multiple sclerosis, amyotrophic lateral sclerosis, syringomyelia, tabes dorsalis;
  • peripheral neuropathies;
  • surgical sympathectomy;
  • coronary heart and/or artery disease;
  • anemia;
  • hypertension;
  • renal function abnormalities;
  • diabetes mellitus;
  • pituitary insufficiency;
  • adrenal insufficiency;
  • hypothyroidism; and
  • medications known to affect the cardiovascular system.
  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): NCT00237770


Locations
United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: William Bauman, MD VA Medical Center, Bronx
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00237770     History of Changes
Other Study ID Numbers: B3600-R
First Submitted: October 7, 2005
First Posted: October 12, 2005
Results First Submitted: September 24, 2013
Results First Posted: May 19, 2014
Last Update Posted: May 19, 2014
Last Verified: April 2014

Keywords provided by VA Office of Research and Development:
Blood Pressure
Cardiovascular Autonomic Control
Nitric Oxide
NOS Inhibitor
Orthostatic Hypotension
Spinal Cord Injury
Tetraplegia

Additional relevant MeSH terms:
Spinal Cord Injuries
Hypotension
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents