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A Study of Autonomic Dynamic Dysfunction to Predict Infections After Spinal Cord Injury.

Recruiting
18 years of age
Both
Phase N/A

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Overview

The study is designed to investigate whether autonomic shifts (dysautonomia, sympatho-vagal instability) that develop after SCI have value in predicting SCI-associated infections (SCI-AI). SCI-AI impair outcomes by (1) reducing the intrinsic neurological recovery potential and (2) increasing mortality. Heart Rate Variability (HRV) data will be tracked in both the time and frequency domains to discriminate between the relative contribution of sympathetic and parasympathetic innervation to changes in HRV. The ability to predict infections will enable novel treatments thereby reducing infection-associated mortality and improving neurological and functional outcomes.

Eligibility

Inclusion Criteria:

  1. Patients with acute isolated spinal cord injury (AIS A-D) planned for surgical stabilization and decompression, lesion may include more than 1 segment
  2. Patients with acute isolated spinal fracture, lesion may include more than 1 segment
  3. Legal age of the patient
  4. Documented informed consent of the patient

Exclusion Criteria:

  1. Non-traumatic spinal cord injury
  2. Concomitant traumatic brain injury (TBI) (definition: i) patient with severe TBI (Glasgow Coma Scale ≤ 8) and ii) patients with intracranial pressure monitoring sensors)
  3. Neoplasia and/or antineoplastic therapy
  4. Pregnancy, lactation

Study details

Trauma, Spinal Cord, SPINAL Fracture

NCT03253952

Ohio State University

25 January 2024

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