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

The Ohio State University

Status

Active, not recruiting

Conditions

Trauma, Spinal Cord

SPINAL Fracture

Study type

Observational

Funder types

Other

Identifiers

NCT03253952

2016H0369

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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