UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051190 |
|---|---|
| Receipt number | R000058383 |
| Scientific Title | Serum Alkaline Phosphatase and outcome in ARDS Patients A retrospective observational study |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/05/29 20:03:44 |
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Basic information
Public title
Serum Alkaline Phosphatase and outcome in ARDS Patients
A retrospective observational study
Acronym
Serum Alkaline Phosphatase and outcome in ARDS Patients
Scientific Title
Serum Alkaline Phosphatase and outcome in ARDS Patients
A retrospective observational study
Scientific Title:Acronym
Serum Alkaline Phosphatase and outcome in ARDS Patients
Region
| Africa |
Condition
Condition
Acute respiratory distress syndrome and serum alkaline phosphatase
Classification by specialty
| Pneumology | Clinical immunology | Anesthesiology |
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary aim of the study will be to evaluate the relevance between serum ALP and ARDS severity; and secondary to correlate between clinical improvement or deterioration of clinical parameters and serum ALP level
Basic objectives2
Others
Basic objectives -Others
Correlate between clinical improvement or deterioration of clinical parameters and serum ALP level
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary aim of the study will be to evaluate the relevance between serum ALP and ARDS severity
Key secondary outcomes
Correlate between clinical improvement or deterioration of clinical parameters and serum ALP level
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Clinical data for assessment of progress of patients: Oxygenation, ventilatory and lung mechanics, and radiological data:
ABGs (Pao2&PaCo2)
PaO2/FiO2 ratio
PEEP and peak and plateau pressures.
Lung ultrasound
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who will be included conformed to the diagnostic criteria of acute respiratory distress syndrome
Key exclusion criteria
Exclusion of patients with liver and kidney diseases, cancer patients and autoimmune illness and patients who develop marked hemodynamic instability or need vasoactive drugs.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Wafiya |
| Middle name | R |
| Last name | Mahdy |
Organization
Faculty of medicine Menofia university
Division name
Anesthesia, Intinsve care and pain management department
Zip code
32511
Address
Faculty of medicine, Menofia University, Egypt
TEL
00201094245826
wafia.mahdi@med.menofia.edu.eg
Public contact
Name of contact person
| 1st name | Ghada |
| Middle name | |
| Last name | Hassan |
Organization
Menofia University
Division name
Anesthesia, Intinsve care and pain management department
Zip code
32511
Address
Faculty of medicine, Menofia University, Egypt
TEL
00201001592001
Homepage URL
ghada.ibrahim@med.menofia.edu.eg
Sponsor or person
Institute
Faculty of medicine Menofia university, Egypt
Institute
Department
Personal name
Funding Source
Organization
Faculty of medicine Menofia 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
Faculty of medicine, Menofia University, Egypt
Address
Egyopt, Shebin El-Kom, Yassin Abdel Ghaffar street
Tel
00201094245826
wafia.mahdi@med.menofia.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
Anesthesia Department, Faculty of medicine Menofia university, Egypt
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 29 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058383
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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