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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03253952
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : March 15, 2022
Sponsor:
Information provided by (Responsible Party):
Jan Schwab, 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.

Condition or disease
Trauma, Spinal Cord SPINAL Fracture

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PROSPECT ADDITION SCI - A PROSPECTive Study of Autonomic Dynamic Dysfunction to Predict infecTIONs After Spinal Cord Injury
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Group/Cohort
Traumatic Spinal Cord Injury
Observational study - monitoring immune response and heart rate variability
Traumatic Spine Fracture, Control Group
Observational study - monitoring immune response and heart rate variability acting as a control group.



Primary Outcome Measures :
  1. Sympatho-vagal instability as an identifier for patients at risk for Spinal Cord Injury Associated Infections [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
SCI patients (n=50 subjects), Isolated Spinal fracture patients (n=10)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253952


Contacts
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Contact: Nathaniel B Dusseau, II, BS, MS 614-293-1454 nathaniel.dusseau@osumc.edu

Locations
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United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Nathaniel B. Dusseau, II, BS, MS    614-293-1454    nathaniel.dusseau@osumc.edu   
Contact: Monica Lichi, MS, MBA, CCRP    614-293-3802    monica.lichi@osumc.edu   
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Jan M Schwab, MD, PhD Ohio State University
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Responsible Party: Jan Schwab, Director of Spinal Cord Medicine, Ohio State University
ClinicalTrials.gov Identifier: NCT03253952    
Other Study ID Numbers: 2016H0369
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Fractures
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Spinal Injuries
Back Injuries
Fractures, Bone