UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054147 |
|---|---|
| Receipt number | R000061831 |
| Scientific Title | Anion gap method for lithium poisoning identification: A single-center retrospective observational study |
| Date of disclosure of the study information | 2024/04/14 |
| Last modified on | 2024/10/13 10:57:17 |
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Basic information
Public title
Anion gap method for lithium poisoning identification: A single-center retrospective observational study
Acronym
Anion gap method for lithium poisoning identification
Scientific Title
Anion gap method for lithium poisoning identification: A single-center retrospective observational study
Scientific Title:Acronym
Anion gap method for lithium poisoning identification
Region
| Japan |
Condition
Condition
Lithium poisoning
Classification by specialty
| Psychiatry | Laboratory medicine | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the feasibility of utilizing the anion gap as a diagnostic tool for detecting lithium intoxication. Additionally, we would examine the effectiveness of correcting the anion gap for albumin and lactate values compared to conventional anion gap calculation methods.
Basic objectives2
Others
Basic objectives -Others
Investigation of diagnostic accuracy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of the anion gap for lithium poisoning
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients whose lithium blood levels were assessed at the emergency department and admitted to the Emergency Medical Center of Niigata University Medical and Dental Hospital between January 2014 and December 2023.
Key exclusion criteria
In case of missing data
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Honda |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Critical Care Medicine
Zip code
951-8510
Address
754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata, Japan
TEL
025-223-6161
h.honda0914@gmail.com
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Honda |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Critical Care Medicine
Zip code
951-8510
Address
754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata, Japan
TEL
025-223-6161
Homepage URL
h.honda0914@gmail.com
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Hiroyuki Honda
Funding Source
Organization
Self-funding
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
Ethics Committee of Niigata University
Address
757, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata, Japan
Tel
025-227-2625
ethics@adm.niigata-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/abs/10.1080/15563650.2024.2380771
Number of participants that the trial has enrolled
18
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
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical information will be analyzed based on data obtained from medical records. It is important to note that the information used in this study have been previously collected during general practice and will not be newly obtained.
Management information
Registered date
| 2024 | Year | 04 | Month | 14 | Day |
Last modified on
| 2024 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061831
