UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019258 |
|---|---|
| Receipt number | R000022222 |
| Scientific Title | Diagnostic value of heart rate abnormalities at rest in children with abdominal pain |
| Date of disclosure of the study information | 2015/10/09 |
| Last modified on | 2017/05/09 17:14:52 |
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Basic information
Public title
Diagnostic value of heart rate abnormalities at rest
in children with abdominal pain
Acronym
Diagnostic value of heart rate abnormalities at rest
in children with abdominal pain
Scientific Title
Diagnostic value of heart rate abnormalities at rest
in children with abdominal pain
Scientific Title:Acronym
Diagnostic value of heart rate abnormalities at rest
in children with abdominal pain
Region
| Japan |
Condition
Condition
abdominal pain
Classification by specialty
| Pediatrics | Emergency medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is stated in the textbook that heart rate abnormality such as abnormal tachycardia is not a indicator of severe illness in patients with acute abdominal pain (Cope, 3rd ed.). However, there is few studies exactly dealing with diagnostic value of heart rate abnormalities in patients with abdominal pain. Our objective is to determine whether heart rate abnormalities raises the likelihood of severe illness that require special medical or surgical intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between
1) heart rate abnormalities at the triage at rest in children with abdominal pain and
2) potentially life- or organ- threatening diseases.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 18 | years-old | > |
Gender
Male
Key inclusion criteria
Children with abdominal pain who visited emergency department at Tokyo Metropolitan Children's Medical Center.
Key exclusion criteria
Those without triage.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Itaru Hayakawa |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
General Pediatrics
Zip code
Address
2-8-29, Musashidai, Fuchu-shi, Tokyo, Japan
TEL
+81-42-300-5111
ihayakawa-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Itaru Hayakawa |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
General Pediatrics
Zip code
Address
2-8-29, Musashidai, Fuchu-shi, Tokyo, Japan
TEL
+81-42-300-5111
Homepage URL
ihayakawa-tky@umin.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center Department of General Pediatrics
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Tokyo Metropolitan Children's Medical Center
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.1016/j.ajem.2017.01.032
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe the following:
1. final diagnosis
2. wheter the final diagnosis is functional/non-organ-threatening or organic/organ-threatening
3. patients' age, sex, past medical history
4. first impression
5. heart rate abnormality
6. vital signs
7. result of the triage
8. organ dysfunction
Management information
Registered date
| 2015 | Year | 10 | Month | 07 | Day |
Last modified on
| 2017 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022222
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
