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Baseline Cardiovascular Measurements in Pediatric Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT01599455
Recruitment Status : Recruiting
First Posted : May 16, 2012
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):

May 14, 2012
May 16, 2012
August 3, 2017
May 2012
May 2019   (Final data collection date for primary outcome measure)
Blood pressure readings [ Time Frame: at regularly scheduled medical appointments ]
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Complete list of historical versions of study NCT01599455 on ClinicalTrials.gov Archive Site
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Baseline Cardiovascular Measurements in Pediatric Spinal Cord Injury
Cardiovascular Measurements at Baseline and During Cystometry in Pediatric Spinal Cord Injury

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Children and adolescents with spinal cord injury who are admitted for spinal cord injury rehabilitation program, visiting outpatient clinics, or undergoing scheduled urodynamic study
Spinal Cord Injury
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  • Inpatient
    Youths admitted for inpatient rehabilitation training
  • Outpatient
    Youths visiting outpatient clinics
  • Urodynamic study
    Youths who undergo scheduled urodynamic study

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
315
May 2022
May 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
No
Contact: Kathy Zebracki, PhD 773-385-5832 kzebracki@shrinenet.org
Contact: Lawrence C Vogel, MD 773-385-5528 lvogel@shrinenet.org
United States
 
 
NCT01599455
SHC-SCI-CV
No
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Plan to Share IPD: No
Kathy Zebracki, Shriners Hospitals for Children
Shriners Hospitals for Children
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Shriners Hospitals for Children
August 2017