UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042795 |
|---|---|
| Receipt number | R000048853 |
| Scientific Title | A Multicenter Prospective Observational Study of Sodium-glucose Cotransporter-2 Inhibitors-Associated Postoperative Ketoacidosis |
| Date of disclosure of the study information | 2021/01/01 |
| Last modified on | 2024/12/24 14:24:56 |
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Basic information
Public title
A Multicenter Prospective Observational Study of Sodium-glucose Cotransporter-2 Inhibitors-Associated Postoperative Ketoacidosis
Acronym
The SAPKA Study
Scientific Title
A Multicenter Prospective Observational Study of Sodium-glucose Cotransporter-2 Inhibitors-Associated Postoperative Ketoacidosis
Scientific Title:Acronym
The SAPKA Study
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the incidence of postoperative ketoacidosis in adult patients with diabetes taking SGLT2 inhibitors and undergoing surgery under general anesthesia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of ketoacidosis within 3 days after surgery
Key secondary outcomes
Risk factors for developing 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Written informed consent
2. Aged older than 19 yr
3. Diagnosed with diabetes
4. Undergoing surgery under general anesthesia
5. Taking one of the SGLT2 inhibitors listed below
a. Apleway
b. Canaglu
c. Canalia
d. Deberza
e. Forxiga
f. Jardiance
g. Lusefi
h. Suglat
i. Sujanu
j. Tradiance
Key exclusion criteria
1. Diagnosed with ketoacidosis at the screening or anesthesia induction
2. Secessed SGLT2 inhibitors more than one week prior to surgery
3. Surgery is performed without general anesthesia
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Seki |
Organization
Kyorin University School of Medicine
Division name
Department of Anesthesiology
Zip code
181-8611
Address
6-20-2 Shinkawa Mitaka, Tokyo Japan
TEL
0422-43-1504
hseki@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Seki |
Organization
Kyorin University School of Medicine
Division name
Department of Anesthesiology
Zip code
181-8611
Address
6-20-2 Shinkawa Mitaka, Tokyo Japan
TEL
0422-43-1504
Homepage URL
hseki@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science
Grant-in-Aid for Scientific Research (C) (Grant Number 21K06676)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine Research Ethics Committee, Kyorin University
Address
6-20-2 Shinkawa Mitaka, Tokyo Japan
Tel
0422-47-5511
rec@ks.kyorin-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
杏林大学医学部附属病院（東京都）、東北大学病院（宮城県）、東京慈恵会医科大学附属病院（東京都）、九州大学病院（福岡県）、札幌医科大学附属病院（北海道）、日本大学病院（東京都）、浜松医科大学医学部附属病院（静岡県）、秋田大学医学部附属病院（秋田県）、福岡大学病院（福岡県）、宮崎大学医学部附属病院（宮崎県）、弘前大学医学部附属病院（青森県）、山形大学医学部附属病院（山形県）、東京歯科大学市川総合病院（千葉県）、熊本大学病院（熊本県）、福井大学医学部附属病院（福井県）、川崎医科大学附属病院（岡山県）、信州大学医学部附属病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2021 | 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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 07 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 07 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Urine samples will be collected on postoperative days (PODs) 0, 1, 2, and 3. If urine ketone is detected, arterial or venous blood will be collected to measure blood pH, bicarbonate, glucose level, and electrolyte, including sodium, potassium, and chloride.
Ketoacidosis is defined as urine ketone body positive and a blood pH of less than 7.30.
The incidence of SGLT2 inhibitor-associated postoperative ketoacidosis (SAPKA) will be calculated as the number of patients fulfilling the SAPKA diagnostic criteria divided by the total number of participants with data from at least one postoperative urinalysis. The result (%) will be reported with the 95% confidence interval. Based on the anticipated small number of SAPKA cases, sensitivity analysis will be performed using bootstrap resampling methods.
If >10% of recruited patients do not have postoperative urinalysis data, we will impute missing data using the multiple imputation by chained equations method. The number of imputations will be determined based on the percentages of missing values, and the results for the imputations will be pooled using Rubin's rule.
If we identify >10 SAPKA cases during the study period, we will conduct a nested case-control analysis to explore the perioperative variables that are associated with SAPKA. Multivariable logistic regression models will be constructed to identify any risk factors for SAPKA, and perioperative variables with high clinical relevance will be incorporated into the multivariable models.
Management information
Registered date
| 2020 | Year | 12 | Month | 20 | Day |
Last modified on
| 2024 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048853
