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NCT03253952 · ClinicalTrials.gov registry record
A Study of Autonomic Dynamic Dysfunction to Predict Infections After Spinal Cord Injury.
A clinical trial of Trauma, Spinal Cord and SPINAL Fracture, sponsored by Ohio State University.
- Active
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT03253952: Active study of Trauma, Spinal Cord and SPINAL Fracture, sponsored by Ohio State University.
NCT03253952 is a study of Trauma, Spinal Cord and SPINAL Fracture that is active but no longer recruiting, run by Ohio State University. The registered enrollment target is 50 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03253952, a study of Trauma, Spinal Cord and SPINAL Fracture, is active but no longer recruiting, sponsored by Ohio State University.
- ACTIVE NOT RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Study Locations (1)
Ohio
- The Ohio State University Wexner Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-09-29 |
| Est. Completion | 2027-12-31 |
What the registry record for NCT03253952 still lists
NCT03253952 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 2 conditions, with Trauma, Spinal Cord appearing as the primary indexed condition, and to 0 interventions.
NCT03253952 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT03253952 about?
NCT03253952 is a clinical study titled "A Study of Autonomic Dynamic Dysfunction to Predict Infections After Spinal Cord Injury.". 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 mortali...
What is the current status of trial NCT03253952?
This trial is currently active not recruiting. The enrollment target is 50 participants. The study started on 2017-09-29. Estimated completion is 2027-12-31.
What conditions does trial NCT03253952 study?
This clinical trial studies the following conditions: Trauma, Spinal Cord, SPINAL Fracture.
Who is sponsoring clinical trial NCT03253952?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03253952 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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