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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03253952

Enrollment

Registered

2017-08-18

Start date

2017-09-29

Completion date

2027-12-31

Last updated

2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SPINAL Fracture, Trauma, Spinal Cord

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results