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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041468
Receipt No. R000047339
Scientific Title Evaluation of type and circadian rhythm of delirium in Children following corrective cardiac surgery using cardiopulmonary bypass
Date of disclosure of the study information 2021/04/01
Last modified on 2020/08/19

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Basic information
Public title Evaluation of type and circadian rhythm of delirium in Children following corrective cardiac surgery using cardiopulmonary bypass
Acronym Evaluation of type and circadian rhythm of delirium in Children following corrective cardiac surgery using cardiopulmonary bypass
Scientific Title Evaluation of type and circadian rhythm of delirium in Children following corrective cardiac surgery using cardiopulmonary bypass
Scientific Title:Acronym Evaluation of type and circadian rhythm of delirium in Children following corrective cardiac surgery using cardiopulmonary bypass
Region
Africa

Condition
Condition recruiting
Classification by specialty
Cardiology Neurology Anesthesiology
Cardiovascular surgery Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 evaluate the circadian rhythm of delirium in children who will be admitted to our pediatric cardiothoracic intensive care unit after cardiopulmonary bypass surgery
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes evaluate the circadian rhythm of delirium in children who will be admitted to our pediatric cardiothoracic intensive care unit after cardiopulmonary bypass surgery
Key secondary outcomes assess the common type of delirium in thosepatients as well and severity of each type

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
1 years-old <
Age-upper limit
16 years-old >
Gender Male and Female
Key inclusion criteria All pediatric patients who will be admitted for postoperative ICU after having corrective open cardiac surgery using cardiopulmonary bypass machine with age less than 16 years.
Key exclusion criteria Patient's parents/guardian refusal, previous cardiac surgery or any neurological abnormalities.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Mohamed
Middle name Ahmed Maher
Last name Elmorsy
Organization Faculty of medicine - Mansoura university-
Egypt
Division name Anesthesia and surgical ICU department
Zip code 35516
Address 2 EL Gomhouria st., Mansoura, Egypt
TEL 20112582480
Email m.am.elmorsy@gmail.com

Public contact
Name of contact person
1st name Hani
Middle name Ibrahim
Last name Taman
Organization Faculty of medicine - Mansoura university- Egypt
Division name Anesthesia and surgical ICU department
Zip code 35516
Address 2 EL Gomhouria st., Mansoura, Egypt
TEL 01008288242
Homepage URL
Email hAni_taman@yahoo.com

Sponsor
Institute Faculty of medicine - Mansoura university- Egypt
Institute
Department

Funding Source
Organization Faculty of medicine - Mansoura university- Egypt
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of Faculty of medicine - Mansoura university- Egypt
Address 2 EL Gomhouria st., Mansoura, Egypt
Tel 201092127930
Email irb_staff@mans.edu.eg

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 Mansoura university children hospital MUCH , Faculty of medicine - Mansoura university- Egypt

Other administrative information
Date of disclosure of the study information
2021 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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 Open public recruiting
Date of protocol fixation
2020 Year 03 Month 06 Day
Date of IRB
2020 Year 03 Month 29 Day
Anticipated trial start date
2020 Year 03 Month 30 Day
Last follow-up date
2021 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cornell Assessment of Pediatric Delirium (CAPD) will be used for delirium assessment. It is considered as an easy and approachable bedside test suitable for use in children (Patel et al., 2009). Statistical Manual of Mental Disorders, 5th ed. (DSM-V) criteria for the diagnosis of delirium is incorporated in CAPD test (Patel et al., 2017). In order to obtain accurate results, fluctuating change in awareness and cognition is important to diagnose delirium, also it is possible discriminate delirium from other causes of altered mental status in critically ill children

Management information
Registered date
2020 Year 08 Month 19 Day
Last modified on
2020 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047339

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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