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

Active, not recruiting

• Conditions: SPINAL Fracture; Trauma, Spinal Cord

• Registration Number: NCT03253952
• Lead Sponsor: Ohio State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-18
• Study Start: 2017-09-29
• Primary Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sympatho-vagal instability as an identifier for patients at risk for Spinal Cord Injury Associated Infections	At all study time-points for a period of 24hours.	Determining whether discrete signs of loss of autonomic control (dysautonomia), not meeting defined criteria of full-autonomic dysreflexia, also renders patients "at risk" for developing infections.

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States