drugset / Trial / NCT02919917
Treatment of Post-SCI Hypotension
Phase 2/3
Completed
66 enrolled
James J. Peters Veterans Affairs Medical Center
Icahn School of Medicine at Mount Sinai · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
While treatment strategies for OH have been identified for use in persons with acute SCI, the field of SCI medicine lacks a gold standard for treatment thresholds and well-defined outcome parameters. Comprehensively documenting the impact of orthostatic hypotension (OH), regardless of symptoms, during acute rehabilitation and identifying the effects of two different treatment approaches on therapy participation and adherence to an intended rehabilitation plan could have a significant impact on clinical practice in the acute rehabilitation setting following SCI.
Timeline
- Start
- 2017-06-01
- Primary completion
- 2021-09-01
- Completion
- 2021-09-01
Publications
- Wecht JM, Weir JP, Huang V, Escalon MX, Bryce TN. Treatment of Orthostatic Hypotension During Acute Inpatient Rehabilitation After Spinal Cord Injury: Usual Care vs. Anti-hypotensive Therapy. Am J Hypertens. 2024 Jul 15;37(8):554-560. doi: 10.1093/ajh/hpae057.
- Vaccaro DH, Weir JP, Noonavath M, Bryce TN, Escalon MX, Huang V, Delgado A, Wecht JM. Orthostatic systemic and cerebral hemodynamics in newly injured patients with spinal cord injury. Auton Neurosci. 2022 Jul;240:102973. doi: 10.1016/j.autneu.2022.102973. Epub 2022 Mar 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fludrocortisone | Other / unclassified | 0.1 mg | — |
| Subject | Fludrocortisone | Other / unclassified | 0.2 mg | — |
| Subject | Midodrine | Small molecule | 5 mg | — |
| Subject | Midodrine | Small molecule | 10 mg | — |
| Subject | Midodrine | Small molecule | 15 mg | — |
| Subject | Midodrine | Small molecule | 20 mg | — |