Abstract | INTRODUCTION: METHODS AND ANALYSIS: This multicentre, prospective, observational study will recruit 750 adult Japanese patients with diabetes who are receiving SGLT2 inhibitors and undergoing surgery under general anaesthesia. Urine samples will be collected on postoperative days 0, 1, 2 and 3. Blood gas analysis will be performed when urine ketone positivity is detected. The incidence of postoperative ketoacidosis will be identified based on urine ketone positivity and a blood pH of ≤7.3. The study will also collect data to identify risk factors for SAPKA. ETHICS AND DISSEMINATION: The study protocol has been approved by the ethics committee of Kyorin University (approval number: 785, 26 October 2020) and local ethical approval will be required at each participating centre. Study findings will be submitted to peer-reviewed journals and abstracts will be submitted to relevant national and international meetings. TRIAL REGISTRATION NUMBER: UMIN000042795.
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Authors | Hiroyuki Seki, Norifumi Kuratani, Toshiya Shiga, Yudai Iwasaki, Kanae Karita, Kazuki Yasuda, Tomoko Yorozu |
Journal | BMJ open
(BMJ Open)
Vol. 11
Issue 11
Pg. e049592
(11 23 2021)
ISSN: 2044-6055 [Electronic] England |
PMID | 34815277
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
Chemical References |
- Hypoglycemic Agents
- Sodium-Glucose Transporter 2 Inhibitors
- Sodium
- Glucose
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Topics |
- Adult
- Diabetes Mellitus, Type 2
(drug therapy)
- Diabetic Ketoacidosis
(chemically induced)
- Glucose
- Humans
- Hypoglycemic Agents
(adverse effects)
- Ketosis
(chemically induced)
- Multicenter Studies as Topic
- Observational Studies as Topic
- Prospective Studies
- Sodium
- Sodium-Glucose Transporter 2 Inhibitors
(adverse effects)
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