Baseline Cardiovascular Measurements in Pediatric Spinal Cord Injury

NCT ID: NCT01599455

Last Updated: 2020-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2020-08-31

Brief Summary

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Following spinal cord injury (SCI), the body loses normal control of blood pressure and heart rate, and there is a risk of sudden and dangerous increases in blood pressure, namely, autonomic dysreflexia (AD). It is important to be aware of baseline blood pressures and heart rates in individuals in order to detect AD. However, baseline values vary in developing children, and may be more variable in children with SCI. Thus, the objective of this study is to determine baseline blood pressure and heart rate measurements in children with SCI during rest and during urodynamic testing.

The investigators hypothesize that 1) blood pressures will increase with increasing age and body mass index; 2) heart rate will decrease with increasing age; 3) blood pressures will increase with increase in bladder filling; 4) blood pressures will increase will increase with increasing duration of injury.

Detailed Description

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Conditions

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Spinal Cord Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Inpatient

Youths admitted for inpatient rehabilitation training

No interventions assigned to this group

Outpatient

Youths visiting outpatient clinics

No interventions assigned to this group

Urodynamic study

Youths who undergo scheduled urodynamic study

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* children and adolescents with spinal cord injury
* age 18 years or younger

Exclusion Criteria

* known history of hypertension, cardiac, renal, or thyroid disease
* recent surgical procedure less than 2 weeks prior to admission or visit
* fever or signs of active infection or inflammation
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shriners Hospitals for Children

OTHER

Sponsor Role lead

Responsible Party

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Kathy Zebracki

Clinical Psychologist, Director of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shriners Hospitals for Children - Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Zebracki K, Hwang M, Patt PL, Vogel LC. Autonomic cardiovascular dysfunction and vitamin D deficiency in pediatric spinal cord injury. J Pediatr Rehabil Med. 2013;6(1):45-52. doi: 10.3233/PRM-130236.

Reference Type RESULT
PMID: 23481891 (View on PubMed)

Hwang M, Zebracki K, Betz RR, Mulcahey MJ, Vogel LC. Normative blood pressure and heart rate in pediatric spinal cord injury. Top Spinal Cord Inj Rehabil. 2013 Spring;19(2):87-95. doi: 10.1310/sci1902-87.

Reference Type RESULT
PMID: 23671378 (View on PubMed)

Other Identifiers

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SHC-SCI-CV

Identifier Type: -

Identifier Source: org_study_id

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