Clinical Trial: Treatment of Post-SCI Hypotension

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Treatment of Post-SCI Hypotension: A Randomized Controlled Study of Usual Care Versus Anti Hypotension Therapy

Brief 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.

Detailed Summary:

Baseline Testing: Subjects will visit the testing laboratory on the SCI Rehabilitation Unit for baseline data collection, prior to initiation of the treatment protocol. Upon arrival, subjects will be placed in the supine position on an adjustable surface for instrumentation, which will be conducted in a quiet, dimly lit, thermo-neutral testing environment. After a 20-minute period of quiet rest, a 10-minute sample of supine heart rate (HR), respiratory rate, BP and CBF velocity data will be collected. Venous occlusion plethysmography (Vop) will be collected in the supine position for two 5-minute periods. After the supine data collection, subjects will be passively moved into the seated position, with the knees and hips at 90°, for the 10-minute seated data collection period. Subjects will be asked to complete two surveys related to AD and OH symptomology. Finally, subjects will be fitted with a 24-hour HR and BP monitor and will be asked to go about their normal routine. A record of all daily activities including rehabilitation, medications, eating and sleep/wake times will be logged. This testing session should take approximately 1 hour.

Daily Testing: Every day supine and seated BP measurements will be performed at least three times per day. These BP assessments will be recorded in the supine and seated positions in the subject's room by a patient care associate who is blind to the study arm allocation. For every scheduled physical and occupational therapy session, the treating therapist will be asked to complete a brief 6 question survey to document if that session was altered, disrupted, or missed due to hypotension (Therapist Reported Version). The subject will also be asked to complete a brief survey to determine if from their perspective the session was altered, disrupted or missed due to hypotension (Subject Reported Version). In addition, every day a co-inv
Sponsor: James J. Peters Veterans Affairs Medical Center

Current Primary Outcome:

• Rehabilitation [ Time Frame: Up to 5 years ]
  To compare time spent actively involved in rehabilitation program between two groups
• Systolic Blood Pressure [ Time Frame: Up to 5 years ]
  To compare time spent at a systolic BP > 140 mmHg; Compare time spent at a systolic BP < 110 mmHg for males and < 100 mmHg for females. This is based on twice-weekly 24-hour BP observations

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Orthostatic Hypotension and Autonomic Dysreflexia [ Time Frame: Up to 5 years ]
  To compare groups on OH and AD symptoms by survey
• Cerebral Blood Flow [ Time Frame: Up to 5 years ]
  To compare seated middle cerebral artery blood flow velocity between the two groups

Original Secondary Outcome: Same as current

Information By: James J. Peters Veterans Affairs Medical Center

Dates:
Date Received: September 22, 2016
Date Started: January 2017
Date Completion: September 2021
Last Updated: January 13, 2017
Last Verified: September 2016