UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045826 |
|---|---|
| Receipt number | R000052316 |
| Scientific Title | The perioperative association between taking sodium-glucose co-transporter (SGLT) 2 inhibitors and ketoacidosis: a single-center, retrospective, observational, cohort study |
| Date of disclosure of the study information | 2021/10/22 |
| Last modified on | 2023/10/25 15:37:53 |
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Basic information
Public title
The perioperative association between taking sodium-glucose co-transporter (SGLT) 2 inhibitors and ketoacidosis: a single-center, retrospective, observational, cohort study
Acronym
The perioperative association between SGLT2 inhibitors and ketoacidosis
Scientific Title
The perioperative association between taking sodium-glucose co-transporter (SGLT) 2 inhibitors and ketoacidosis: a single-center, retrospective, observational, cohort study
Scientific Title:Acronym
The perioperative association between SGLT2 inhibitors and ketoacidosis
Region
| Japan |
Condition
Condition
Surgical patients taking SGLT2 inhibitors and postoperative care in general ICU
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Ophthalmology |
| Dermatology | Oto-rhino-laryngology | Orthopedics |
| Urology | Oral surgery | Neurosurgery |
| Cardiovascular surgery | Plastic surgery | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine associations between taking SGLT2 inhibitors and postoperative ketoacidosis among the surgical patients. To avoid postoperative ketoacidosis, SGLT2 inhibitors is recommend to stop 3 days before operation from the view point of diabetes. However, for heart failure, SGLT2 inhibitor is a diuretic and it should be continued immediately before surgery. We examined prevalence of ketoacidosis among the postoperative patients taking SGLT2 inhibitor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To examine prevalence of postoperative ketoacidosis in the patients taking SGLT2 inhibitors.
Key secondary outcomes
Need of intervention for ketoacidosis.
Relations between incidence of ketoacidosis among postoperative patients taking SGLT2 inhibitor and the period stopping the drug.
Incidence of intraoperative ketoacidosis.
Complications for circulatory dynamic.
Relation between strength of surgical stress and incidence of ketoacidosis.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Surgical patients taking oral SGLT2 inhibitors and postoperative care in our general ICU
2) Surgical patients aged over 18.
Key exclusion criteria
1) Surgical patients not taking oral SGLT2 inhibitor
2) Surgical patients who require emergency surgery
3) Surgical patients who were judged to be inappropriate as subjects by the study investigators
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshihito |
| Middle name | |
| Last name | Fujita |
Organization
Aichi Medical University School of Medicine
Division name
Anesthesiology and Intensive Care Medicine
Zip code
4801195
Address
1-1 Karimata Yazako, Nagakute
TEL
0528349608
fujita.yoshihito.823@mail.aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihito |
| Middle name | |
| Last name | Fujita |
Organization
Aichi Medical University
Division name
Anesthesiology and Intensive Care Medicine
Zip code
4801195
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 School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Aichi Medical University
IRB Contact (For public release)
Organization
Aichi Medical University IRB
Address
1-1 Karimata Yazako
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
| 2021 | Year | 10 | Month | 22 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
a single-center, retrospective, observational, cohort study
Management information
Registered date
| 2021 | Year | 10 | Month | 21 | Day |
Last modified on
| 2023 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052316
