drugset / Trial / NCT02919917

Treatment of Post-SCI Hypotension

NCT02919917 ↗

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

Outcome

Missed primary endpoint

paper Neither the total number of therapy sessions (P = 0.16) nor group assignment (P = 0.83) significantly predicted the number of sessions affected by low BP. PMID 38712567 ↗

Drugs

EvaluationDrugModalityDoseRoute
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 —