Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03253952
Other study ID # 2016H0369
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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.
See also
  Status Clinical Trial Phase
Completed NCT06153511 - Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation N/A
Recruiting NCT03644407 - Galeazzi Spine Surgery RegistryGaleazzi Spine Registry: Prospective Study for Clinical Monitoring
Completed NCT03269851 - Parameters of Neurological Deficit After Thoracolumbar Fractures
Recruiting NCT03316703 - Surgical Treatment of the Thoracolumbar Spine Fractures. N/A
Completed NCT04123106 - Bilateral Erector Spinae Plane Block Versus Local Anesthetic Infiltration for Perioperative Analgesia in Spine Surgery. N/A
Completed NCT00994032 - Quality of Life After Vertebroplasty Versus Conservative Treatment in Patients With Painful Osteoporotic Vertebral Fractures N/A
Completed NCT00343252 - Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis Phase 3
Not yet recruiting NCT05321186 - Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability N/A
Completed NCT02252185 - A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery N/A
Recruiting NCT05170815 - Clariance ErYs Registry
Not yet recruiting NCT04743869 - Calcium Phosphate Versus PMMA Cement in Thoracolumbar Fractures N/A
Terminated NCT03359941 - Acupuncture Treatment for Vertebral Compression Fracture N/A
Completed NCT03272243 - Short Segment vs Long Segment Fixation in Traumatic Dorsolumbar Spine Fractures N/A
Completed NCT00749242 - Comparative Study of Balloon Kyphoplasty and Conservative Treatment Phase 4
Not yet recruiting NCT03312998 - Incidence of Metal Failure During First Year Following Transpedicular Screws Fixation of Dorsolumbar Spine Fracture N/A
Recruiting NCT03911492 - Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study N/A
Recruiting NCT05769114 - Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture N/A
Recruiting NCT03593330 - Neurosurgical Transitional Care Programme N/A
Recruiting NCT06200298 - Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures N/A