UMIN-CTR Clinical Trial

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