UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042795
Receipt No. 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 2021/04/03

* 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 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
Email 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
Email hseki@ks.kyorin-u.ac.jp

Sponsor
Institute Department of Anesthesiology, Kyorin University School of Medicine
Institute
Department

Funding Source
Organization Department of Anesthesiology, Kyorin University School of Medicine
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 Faculty of Medicine Research Ethics Committee, Kyorin University
Address 6-20-2 Shinkawa Mitaka, Tokyo Japan
Tel 0422-47-5511
Email 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 Open public recruiting
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 12 Month 31 Day
Date of closure to data entry
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
2021 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048853

Research Plan
Registered date File name
2020/12/22 SAPKA Study研究計画書1.0.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.