Baseline Cardiovascular Measurements in Pediatric Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Cardiovascular Measurements at Baseline and During Cystometry in Pediatric Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599455
• Other study ID #: SHC-SCI-CV
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

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