UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041468 |
|---|---|
| Receipt number | 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 21:45:45 |
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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
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
hAni_taman@yahoo.com
Sponsor or person
Institute
Faculty of medicine - Mansoura university- Egypt
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047339
| Research Plan | |
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| Registered date | File name |
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