Treatment of Orthostatic Hypotension During Acute Inpatient Rehabilitation After Spinal Cord Injury: Usual Care vs. Anti-hypotensive Therapy.

Abstract

To compare the pharmacological treatment of hypotension and orthostatic hypotension (OH) initiated based upon a blood pressure (BP) threshold, regardless of symptoms (TXT), to usual care pharmacological treatment of symptomatic hypotension (UC), during acute inpatient rehabilitation (AIR) following spinal cord injury (SCI). Block randomization, based on the neurological level of injury as: cervical lesions (C1-C8); high thoracic lesions (T1-T5), and low thoracic lesions (T6-T12), was used to determine responses to the primary question "was the therapy session affected by low BP or concern for low BP development?" Study participants and therapists were unaware of the group assignment. A total of 66 participants enrolled; 25 (38%) in the TXT group, 29 (44%) in the UC group, and 12 (18%) withdrew. Responses to the primary question were recorded for 32 participants, 15 in the TXT, and 17 in the UC group. There was an average of 81 ± 51 therapy sessions/participant in the TXT and 60 ± 27 sessions/participant in the UC group. Of those therapy sessions, low BP or concerns for low BP affected an average of 9 ± 8 sessions/participant in the TXT group and 10 ± 12 sessions/participant in the UC group. 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. These data are not conclusive but indicate that the treatment of asymptomatic hypotension and OH does not increase time spent in therapy compared to UC treatment of symptomatic hypotension and OH in newly injured patients with SCI. #NCT02919917.