UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042225 |
|---|---|
| Receipt number | 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 11:22:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Obstetrics 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
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
fujita.yoshihito.823@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048198
