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 2022/09/08 06:02:19

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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

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 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

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

No longer 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 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

2022 Year 09 Month 08 Day



Link to view the page

Value
https://center6.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