Spinal Cord InjuryNCT01599455
Baseline Cardiovascular Measurements in Pediatric Spinal Cord Injury
An observational study of Spinal Cord Injury, run by Shriners Hospitals for Children at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- children and adolescents with spinal cord injury
- age 18 years or younger
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children - Chicago
Chicago, Illinois, 60707
About this study
Official title: Cardiovascular Measurements at Baseline and During Cystometry 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.
- Conditions
- Spinal Cord Injury
- Keywords
- pediatric spinal cord injury, blood pressure, heart rate, baseline
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inpatient | Youths admitted for inpatient rehabilitation training | |
| Outpatient | Youths visiting outpatient clinics | |
| Urodynamic study | Youths who undergo scheduled urodynamic study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure readings
Measured: at regularly scheduled medical appointments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathy Zebracki, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599455
- Sponsor's protocol ID
- SHC-SCI-CV
- Status last verified
- Aug 2020
- First submitted
- 14 May 2012
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23481891Hwang 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.
PubMed 23671378
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Measurements at Baseline and During Cystometry in Pediatric Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01599455
- Acronym / sponsor ID
- SHC-SCI-CV
- Conditions
- Spinal Cord Injury
- Keywords
- pediatric spinal cord injury, blood pressure, heart rate, baseline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inpatient | – | –Youths admitted for inpatient rehabilitation training |
| Outpatient | – | –Youths visiting outpatient clinics |
| Urodynamic study | – | –Youths who undergo scheduled urodynamic study |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- children and adolescents with spinal cord injury
- age 18 years or younger
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood pressure readings
Time frame: at regularly scheduled medical appointments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Results publication: PubMed 23481891Zebracki 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.
- Results publication: PubMed 23671378Hwang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by Shriners Hospitals for Children at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure readings (time frame: at regularly scheduled medical appointments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01599455, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.