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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019258
Receipt No. 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

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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
Email 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
Email ihayakawa-tky@umin.ac.jp

Sponsor
Institute Tokyo Metropolitan Children's Medical Center Department of General Pediatrics
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022222

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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