Baseline Cardiovascular Measurements in Pediatric Spinal Cord Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Shriners Hospitals for Children
Sponsor:
Information provided by (Responsible Party):
Kathy Zebracki, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT01599455
First received: May 14, 2012
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiovascular Measurements at Baseline and During Cystometry in Pediatric Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • Blood pressure readings [ Time Frame: at regularly scheduled medical appointments ] [ Designated as safety issue: No ]

Estimated Enrollment: 315
Study Start Date: May 2012
Estimated Study Completion Date: May 2022
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Inpatient
Youths admitted for inpatient rehabilitation training
Outpatient
Youths visiting outpatient clinics
Urodynamic study
Youths who undergo scheduled urodynamic study

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children and adolescents with spinal cord injury who are admitted for spinal cord injury rehabilitation program, visiting outpatient clinics, or undergoing scheduled urodynamic study

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599455

Contacts
Contact: Kathy Zebracki, PhD 773-385-5832 kzebracki@shrinenet.org
Contact: Lawrence C Vogel, MD 773-385-5528 lvogel@shrinenet.org

Locations
United States, Illinois
Shriners Hospitals for Children - Chicago Recruiting
Chicago, Illinois, United States, 60707
Principal Investigator: Kathy Zebracki, PhD         
Sub-Investigator: Lawrence C Vogel, MD         
Sub-Investigator: Miriam Hwang, MD         
Sub-Investigator: Patti Mucia, BSN         
Sponsors and Collaborators
Shriners Hospitals for Children
  More Information

Publications:
Responsible Party: Kathy Zebracki, Clinical Psychologist, Director of Psychology, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT01599455     History of Changes
Other Study ID Numbers: SHC-SCI-CV
Study First Received: May 14, 2012
Last Updated: February 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
pediatric spinal cord injury
blood pressure
heart rate
baseline

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 24, 2014