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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01599455
Other study ID # SHC-SCI-CV
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2012
Est. completion date August 2020

Study information

Verified date August 2020
Source Shriners Hospitals for Children
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date August 2020
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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

Study Design


Locations

Country Name City State
United States Shriners Hospitals for Children - Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Blood pressure readings at regularly scheduled medical appointments
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