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NCT01822535 · ClinicalTrials.gov registry record · Phase 4
Body Temperature in Persons With Tetraplegia When Exposed to Cold
A Phase 4 study, sponsored by James J. Peters Veterans Affairs Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT01822535 is a Phase 4 study that has completed, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 30 participants.
The verdict
NCT01822535, a Phase 4 study, has completed, sponsored by James J. Peters Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study 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 maintain Tcore, and the effects of hypothermia to impair mental function in able-bodied (AB) persons, there has been no work to date addressing these issues in persons with tetraplegia. The aim of this study is to determine if exposure of up to 2 hrs to cool temperatures (64°F) causes body core temperature to decrease in persons with tetraplegia and if that decrease is related to a decrease in mental performance. After sitting in a cool (64°F) room for up to 2 hours the investigators hypotheses are: Hypotheses (1): Tcore of most of the persons with tetraplegia will decline approximately 1.8°F (e.g., 98.6 to 96.8°F) while Tcore of controls will not decline at all; (2) Most of the persons with tetraplegia will show a decline in mental performance (memory or clear-headedness) while only some of AB controls will show a decline. The second aim of this study is to determine if a 10 mg dose of an approved blood pressure raising medicine (midodrine hydrochloride) will (1) reduce the decrease in body core temperature and (2) prevent or delay the decline in mental performance in the group with tetraplegia compared to the exact same procedures performed on the day with no medicine (Visit 1) in the same group. Hypotheses (3 \& 4): The changes in blood flow to the skin caused by taking a one-time dose of midodrine will lessen the decline in Tcore and prevent or delay the decline in mental performance compared to the changes in Tcore and mental performance during cool temperature exposure without midodrine in the group with tetraplegia.
Interventions
- DRUG Midodrine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01822535
The ClinicalTrials.gov registry entry for NCT01822535 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James J. Peters Veterans Affairs Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Midodrine hydrochloride is the first listed.
NCT01822535 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01822535 about?
NCT01822535 is a clinical study titled "Body Temperature in Persons With Tetraplegia When Exposed to Cold". 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 maintain Tcore, and the effects of hypothermia to impair mental function in able-bodied (AB) persons,...
What is the current status of trial NCT01822535?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2011-07. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01822535?
The interventions under investigation include: Midodrine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01822535?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
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