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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042225
Receipt No. R000048198
Scientific Title Prevalence of hypomagnesemia and electrolyte disorders in medical surgical intensive care unit settings: a single center, cohort, observational study
Date of disclosure of the study information 2020/10/23
Last modified on 2021/04/24

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Basic information
Public title Prevalence of hypomagnesemia and electrolyte disorders in medical surgical intensive care unit settings, a single center, cohort, observational study
Acronym Hypomagnesemia and electrolyte disorders in ICU
Scientific Title Prevalence of hypomagnesemia and electrolyte disorders in medical surgical intensive care unit settings: a single center, cohort, observational study
Scientific Title:Acronym Hypomagnesemia and electrolyte disorders in ICU
Region
Japan

Condition
Condition Patients who took care in general ICU
Classification by specialty
Medicine in general Surgery in general Gastrointestinal surgery
Vascular surgery Endocrine surgery Obsterics and gynecology
Ophthalmology Dermatology Oto-rhino-laryngology
Orthopedics Urology Oral surgery
Neurosurgery Cardiovascular surgery Aesthetic surgery
Operative medicine Intensive care medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate prevalence of hypomagnesemia in ICU.
Basic objectives2 Others
Basic objectives -Others ncidence of other electrolyte disorders. Coexistence of hypo-iMg with hypo-K or hypo-iCa.. Safety of infusion of iMg. Hypo-iMg after postoperative day 0 and 1. Relation between total Mg and ionized Mg.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate prevalence of hypomagnesemia in ICU.
Key secondary outcomes Incidence of other electrolyte disorders. Coexistence of hypo-iMg with hypo-K or hypo-iCa.. Safety of infusion of iMg. Hypo-iMg after postoperative day 0 and 1. Relation between total Mg and ionized Mg.

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 1) Patients who required care in our general ICU
2) Patients aged over 18.
Key exclusion criteria 1) Patients who did not require measurement of electrolyte in ICU
3) Patients who were judged to be inappropriate as subjects by the study investigators
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Yoshihito
Middle name Yoshihito
Last name Fujita
Organization Aichi Medical University
Division name General ICU
Zip code 480-1195
Address Nagakute
TEL 0561623311
Email fujita.yoshihito.823@mail.aichi-med-u.ac.jp

Public contact
Name of contact person
1st name Fujita
Middle name Yoshihito
Last name Yoshihito
Organization Aichi Medical University
Division name General ICU
Zip code 480-1195
Address 1-1 Karimata Yazako
TEL 0561623311
Homepage URL
Email fujita.yoshihito.823@mail.aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

Funding Source
Organization Aichi Medical University
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 Aichi Medical University IRB
Address 1-1 Karimata Yazako Nagakute
Tel 0561623311
Email aichi-med@esct.bvits.com

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
2020 Year 10 Month 23 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 900
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 No longer recruiting
Date of protocol fixation
2019 Year 07 Month 22 Day
Date of IRB
2019 Year 07 Month 22 Day
Anticipated trial start date
2019 Year 07 Month 23 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To investigate prevalence of hypomagnesemia in ICU. Incidence of other electrolyte disorders. Coexistence of hypo-iMg with hypo-K or hypo-iCa.. Safety of infusion of iMg. Hypo-iMg after postoperative day 0 and 1. Relation between total Mg and ionized Mg.

Management information
Registered date
2020 Year 10 Month 23 Day
Last modified on
2021 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048198

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/10/28 分析用07_03のpreとaf_final_UMINレポジトリ1.xlsx


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