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Baseline Cardiovascular Measurements in Pediatric 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. Identifier: NCT01599455
Recruitment Status : Recruiting
First Posted : May 16, 2012
Last Update Posted : August 3, 2017
Information provided by (Responsible Party):
Kathy Zebracki, Shriners Hospitals for Children

Brief Summary:

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 or disease
Spinal Cord Injury

Study Type : Observational
Estimated Enrollment : 315 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiovascular Measurements at Baseline and During Cystometry in Pediatric Spinal Cord Injury
Study Start Date : May 2012
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Youths admitted for inpatient rehabilitation training
Youths visiting outpatient clinics
Urodynamic study
Youths who undergo scheduled urodynamic study

Primary Outcome Measures :
  1. Blood pressure readings [ Time Frame: at regularly scheduled medical appointments ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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

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 identifier (NCT number): NCT01599455

Contact: Kathy Zebracki, PhD 773-385-5832
Contact: Lawrence C Vogel, MD 773-385-5528

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         
Sub-Investigator: Alicia January, PhD         
Sponsors and Collaborators
Shriners Hospitals for Children

Publications of Results:
Responsible Party: Kathy Zebracki, Clinical Psychologist, Director of Psychology, Shriners Hospitals for Children Identifier: NCT01599455     History of Changes
Other Study ID Numbers: SHC-SCI-CV
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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