UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Diagnostic value of heart rate abnormalities at rest in children with abdominal pain
Title of the study (Brief title)	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	Itaru Hayakawa
Organization	Tokyo Metropolitan Children's Medical Center
Division name	General Pediatrics
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	Itaru Hayakawa
Organization	Tokyo Metropolitan Children's Medical Center
Division name	General Pediatrics
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://dx.doi.org/10.1016/j.ajem.2017.01.032
Results
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