Phase 3 N=16 Treatment

Prevention of Low Blood Pressure in Persons With Tetraplegia

Hypotension · Spinal Cord Injury

Bottom Line

View on ClinicalTrials.gov: NCT00237770 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2014

Primary outcome: Primary: Systolic Blood Pressure During Head-up Tilt — 91.80; 108.10; 112.04; 129.94 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: N-Nitro L-arginine-methylester (L-NAME) (Drug); Head-up Tilt maneuver (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: US Department of Veterans Affairs
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Systolic Blood Pressure During Head-up Tilt	91.80; 108.10; 112.04; 129.94	—

Summary

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00237770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.