Status:
COMPLETED
Body Temperature in Persons With Tetraplegia When Exposed to Cold
Lead Sponsor:
James J. Peters Veterans Affairs Medical Center
Conditions:
Tetraplegia
Hypothermia
Eligibility:
All Genders
18-68 years
Phase:
PHASE4
Brief Summary
The ability to maintain normal body core temperature (Tcore = 98.6°F) is impaired in persons with tetraplegia. Despite the known challenges to the ability of persons with spinal cord injury (SCI) to m...
Detailed Description
This study will investigate the mechanisms contributing to the thermoregulatory fragility in persons with tetraplegia when exposed to cool ambient temperatures that are routinely encountered during ac...
Eligibility Criteria
Inclusion
- (1) Between 18 and 68 years of age;
- (2) Duration of injury ≥ 1 year; (2) Level of SCI C3-T1;
- (3) Euhydration (subjects will be instructed to avoid caffeine and alcohol, maintain normal salt and water intake, and avoid strenuous exercise for 24 hours prior to study)
Exclusion
- (1) Known coronary heart, kidney, peripheral vascular or cerebral vascular disease;
- (2) High blood pressure;
- (3) Untreated thyroid disease;
- (4) Diabetes mellitus;
- (5) Acute illness or infection;
- (6) Dehydration;
- (7) Known allergies to midodrine hydrochloride;
- (8) Smoking;
- (9) Pregnancy
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01822535
Start Date
July 1 2011
End Date
October 1 2015
Last Update
March 4 2016
Active Locations (1)
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1
Center of Excellence for the Medical Consequences of SCI, JJP VAMC, 7A-13
The Bronx, New York, United States, 10468