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OpenTrials
Completed

NCT Number: NCT01599455

Baseline Cardiovascular Measurements 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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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shriners Hospitals for Children - Chicago

Chicago, Illinois, 60707, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Blood pressure readings

    Time frame: at regularly scheduled medical appointments

Sponsors and collaborators

Lead sponsor

Shriners Hospitals for Children

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
May 16, 2012
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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