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

SPINAL Fracture Clinical Trial

Official title:

PROSPECT ADDITION SCI - A PROSPECTive Study of Autonomic Dynamic Dysfunction to Predict infecTIONs After Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03253952
• Other study ID #: 2016H0369
• Status: Recruiting
• Start date: September 29, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2022
• Source: Ohio State University
• Contact: Nathaniel B Dusseau, II, BS, MS
• Phone: 614-293-1454
• Email: nathaniel.dusseau[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• SPINAL Fracture
• Spinal Fractures
• Trauma, Spinal Cord

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sympatho-vagal instability as an identifier for patients at risk for Spinal Cord Injury Associated Infections	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.	At all study time-points for a period of 24hours.