The purpose of this study is to assess the effect of various hemodynamic management strategies on functional neurologic outcomes and non-neurologic adverse events in the first 5 days following acute spinal cord injury (SCI). The hemodynamic management strategies assessed include targeting a mean arterial blood pressure (MAP) goal of 85-90 mmHg, targeting a spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg, or targeting normal hemodynamics, which is a MAP goal of ≥65 mmHg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
228
The treatment team will maintain MAP ≥65 mmHg for the first five days following injury.
The treatment team will maintain MAP 85-90 mmHg for the first five days following injury.
The treatment team will maintain SCPP ≥65 mmHg for the first five days following injury.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGThe severity of a spinal cord injury (SCI) as assessed by the American Spinal Injury Association (ASIA) International Standards for Neurological Classification of Spinal Cord Injury (ISNCSC) motor score
Upper and lower extremities will be assessed, and motor strength at each spinal cord level will be scored from 0 to 5 (0 indicates total paralysis and 5 indicates active movement against full resistance), with a maximum score of 25 for each extremity, totaling 100 for all four extremities. Total score ranges from 0 to 100, with a higher score indicating a better outcome.
Time frame: 6 weeks following injury
Performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score
There are 3 subscales on the SCIM III: self-care (4 items, score ranging from 0-20), respiration and sphincter management (4 items, score ranging from 0-40), and mobility (9 items, score ranging from 0-40). Total score ranges from 0 to 100, with a higher score indicating a better outcome.
Time frame: 6 weeks following injury
Change in motor function as assessed by the American Spinal Injury Association (ASIA) International Standards for Neurological Classification of Spinal Cord Injury (ISNCSC) motor score
Upper and lower extremities will be assessed, and motor strength at each spinal cord level will be scored from 0 to 5 (0 indicates total paralysis and 5 indicates active movement against full resistance), with a maximum score of 25 for each extremity, totaling 100 for all four extremities. Total score ranges from 0 to 100, with a higher score indicating a better outcome.
Time frame: 6 months following injury, 12 months following injury
Change in sensory function as assessed by the American Spinal Injury Association (ASIA) International Standards for Neurological Classification of Spinal Cord Injury (ISNCSC) sensory score
For each side of the body, 28 key sensory points will be assessed by light touch, and each area will be scored from 0 to 2 (0 indicates sensing is absent, 1 indicates sensing is altered, and 2 indicates that sensing is normal). Additionally, for each side of the body 28 key sensory points will be also be assessed by pin prick, and each area will be scored from 0 to 2 (0 indicates sensing is absent, 1 indicates sensing is altered, and 2 indicates that sensing is normal). Scores for light touch and pin prick assessments for both sides of the body will be combined, and the total score ranges from 0 to 224, with a higher score indicating a better outcome.
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Time frame: 6 months following injury, 12 months following injury
Change in performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score
There are 3 subscales on the SCIM III: self-care (4 items, score ranging from 0-20), respiration and sphincter management (4 items, score ranging from 0-40), and mobility (9 items, score ranging from 0-40). Total score ranges from 0 to 100, with a higher score indicating a better outcome.
Time frame: 6 months following injury, 12 months following injury
Number of ICU-free days
Number of ICU-free days = \[30 days - ICU length of stay in days\]. Patients with ICU length of stay \>30 days will be assigned a value of zero ICU-free days.
Time frame: 30 days from baseline
Duration of time (hours) receiving goal caloric requirements by enteric nutrition
Time frame: first 5 days of hospitalization
Number of participants developing a central line-associated blood stream infection
Blood stream infection is defined as bacteremia confirmed by blood culture in the presence of a central venous catheter.
Time frame: Baseline to hospital discharge or 30 days, whichever comes first
Number of participants developing a pneumothorax from central venous catheter insertion
Time frame: Baseline to hospital discharge or 30 days, whichever comes first
Number of participants developing pneumonia
Pneumonia is defined as 10,000 colony forming units (cfu)/milliliter (mL) on bronchioalveolar lavage or mini bronchioalveolar lavage, or clinical diagnosis of pneumonia with subsequent antibiotic treatment.
Time frame: Baseline to hospital discharge or 30 days, whichever comes first
Number of participants developing acute kidney injury using the Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE) criteria
Acute kidney injury using the RIFLE criteria is defined as a 50% increase in serum creatinine from baseline or urine output \<0.5 mL/h for 6 hours.
Time frame: Baseline to hospital discharge or 30 days, whichever comes first
Number of deaths
Time frame: Baseline to hospital discharge or 30 days, whichever comes first