Multicentre prospective observational study of sodium-glucose cotransporter-2 inhibitor-associated postoperative ketoacidosis: the SAPKA study protocol

Seki, Hiroyuki; Kuratani, Norifumi; Shiga, Toshiya; Iwasaki, Yudai; Karita, Kanae; Yasuda, Kazuki; Yorozu, Tomoko

doi:10.1136/bmjopen-2021-049592

Cited by 7 publications

(4 citation statements)

References 19 publications

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“…Third, the external validity of this study remains unclear. In December 2020, the Japan Diabetes Society recommended a preoperative withdrawal period of SGLT2-is to match that of the USFDA guideline [25]. However, in this study, the patients did not stop using SGLT2-is 3 or 4 days before surgery.…”

Section: Discussionmentioning

confidence: 76%

The effect of preoperative sodium-glucose cotransporter 2 inhibitors on the incidence of perioperative metabolic acidosis: A retrospective cohort study

Iwasaki

Sasabuchi

Horikita

et al. 2022

Preprint

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Background Sodium-glucose cotransporter 2 inhibitors (SGLT2-is) are a novel class of anti-hyperglycemic agents. Although several cases of perioperative euglycemic diabetic ketoacidosis have been linked to these medications, the association remains unclear. This study aimed to examine the association between SGLT2-i use and the incidence of perioperative metabolic acidosis with euglycemia, the surrogating outcome of perioperative euglycemic diabetic ketoacidosis. Methods This was a retrospective, matched cohort study, which was conducted in the intensive care unit of a tertiary care facility in Japan. We identified patients aged 20 years or older with diabetes mellitus who received pharmacologic therapy and were admitted to the intensive care unit after elective surgery between April 2014 and March 2019. We extracted the following data from the electronic medical records for matching: age, sex, surgery year, surgical site, hemoglobin A1c level, and prescription for SGLT2-is. Eligible patients were divided into two groups, those who were prescribed SGLT2-is (SGLT2-I group) and those who were not (control group). For each patient in the SGLT2-i group, we randomly selected four patients from the control group matched for the extracted characteristics. The primary outcome was the incidence of metabolic acidosis with an elevated anion gap and euglycemia. The secondary outcome was the lowest pH value of each patient during their intensive care unit stay. Results A total of 155 patients were included in this study. Patients receiving SGLT2-is had comparable characteristics to the control participants; however, the proportions of patients undergoing dialysis were not similar. Metabolic acidosis with euglycemia was seen in 7/31 (22.6%) patients receiving SGLT2-is and in 10/124 (8.1%) control patients (p = 0.047). Conclusions This study shows that the use of SGLT2-is is associated with a significantly higher incidence of metabolic acidosis with euglycemia. Patients receiving SGLT2-is who are scheduled to undergo invasive surgical procedures should be closely monitored for the development of euglycemic diabetic ketoacidosis.

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Section: Discussionmentioning

confidence: 76%

The effect of preoperative sodium-glucose cotransporter 2 inhibitors on the incidence of perioperative metabolic acidosis: A retrospective cohort study

Iwasaki

Sasabuchi

Horikita

et al. 2022

Preprint

Self Cite

View full text Add to dashboard Cite

show abstract

“…Although all of these patients stopped their SGLT2i < 3 days before surgery, it is difficult to conclusively assess the validity of the updated guidelines. We are currently conducting a multicenter observational study to estimate the incidence and precipitating factors of SAPKA [ 97 ]. In the study, the duration of preoperative SGLT2i cessation varied among patients and facilities because the recommendation was changed after the study was initiated, which could help determine the validity of the new recommendation.…”

Section: Discussionmentioning

confidence: 99%

Sodium-glucose cotransporter 2 inhibitor-associated perioperative ketoacidosis: a systematic review of case reports

et al. 2023

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Although the recommended preoperative cessation period for sodium-glucose cotransporter 2 inhibitors (SGLT2is) changed in 2020 (from 24 h to 3–4 days preoperatively) to reduce the risk of SGLT2i-associated perioperative ketoacidosis (SAPKA), the validity of the new recommendation has not been verified. Using case reports, we assessed the new recommendation effectiveness and extrapolated precipitating factors for SAPKA. We searched electronic databases up to June 1, 2022 to assess SAPKA (blood pH < 7.3 and blood or urine ketone positivity within 30 days postoperatively in patients taking SGLT2i). We included 76 publications with 99 cases. The preoperative SGLT2i cessation duration was reported for 59 patients (59.6%). In all cases with available cessation periods, the SGLT2is were interrupted < 3 days preoperatively. No SAPKA cases with > 2-day preoperative cessation periods were found. Many case reports lack important information for estimating precipitating factors, including preoperative SGLT2i cessation period, body mass index, baseline hemoglobin A1c level, details of perioperative fluid management, and type of anesthesia. Our study suggested that preoperative SGLT2i cessation for at least 3 days could prevent SAPKA. Large prospective epidemiologic studies are needed to identify risk factors for SAPKA.

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“…Large clinical trials are needed for meticulous evaluation to overcome these limitations. In Japan, a multicenter observational study examining the incidence of postoperative ketoacidosis associated with SGLT2 inhibitor use is on-going [ 31 ], which might clarify the unresolved issues.…”

Section: Discussionmentioning

confidence: 99%

The effect of preoperative sodium-glucose cotransporter 2 inhibitors on the incidence of perioperative metabolic acidosis: A retrospective cohort study

et al. 2022

Self Cite

View full text Add to dashboard Cite

Background Sodium-glucose cotransporter 2 inhibitors are a novel class of anti-hyperglycemic agents. Although several cases of perioperative euglycemic diabetic ketoacidosis have been linked to these medications, the association remains unclear. This study aimed to examine the association between sodium-glucose cotransporter 2 inhibitor use and the incidence of perioperative metabolic acidosis with euglycemia, the surrogating outcome of perioperative euglycemic diabetic ketoacidosis. Method This was a retrospective, matched cohort study, which was conducted in the intensive care unit of a tertiary care facility in Japan. We identified patients aged 20 years or older with diabetes mellitus who received pharmacologic therapy and were admitted to the intensive care unit after elective surgery between April 2014 and March 2019. We extracted the following data from the electronic medical record for matching: age, sex, surgery year, surgical site, hemoglobin A1c level, and prescription for sodium-glucose cotransporter 2 inhibitors. Eligible patients were divided into two groups, those who were prescribed sodium-glucose cotransporter 2 inhibitors (SGLT2-i group) and those who were not (control group). For each patient in the SGLT2-i group, we randomly selected four patients from the control group matched for the extracted characteristics. The primary outcome was the incidence of metabolic acidosis with an elevated anion gap and euglycemia. The secondary outcome was the lowest pH value of each patient during their ICU stay. Results A total of 155 patients were included in this study. Patients receiving sodium-glucose cotransporter 2 inhibitors had comparable characteristics to control participants; however, the proportions of patients undergoing dialysis were not similar. Metabolic acidosis with euglycemia was seen in 7/31 (22.6%) patients receiving sodium-glucose cotransporter 2 inhibitors and in 10/124 (8.1%) control patients (p = 0.047). Conclusions This study shows that the use of sodium-glucose cotransporter 2 inhibitors is associated with a significantly higher incidence of metabolic acidosis with euglycemia. Patients receiving sodium-glucose cotransporter 2 inhibitors who are scheduled to undergo invasive surgical procedures should be closely monitored for the development of euglycemic diabetic ketoacidosis.

show abstract

Multicentre prospective observational study of sodium-glucose cotransporter-2 inhibitor-associated postoperative ketoacidosis: the SAPKA study protocol

Cited by 7 publications

References 19 publications

The effect of preoperative sodium-glucose cotransporter 2 inhibitors on the incidence of perioperative metabolic acidosis: A retrospective cohort study

The effect of preoperative sodium-glucose cotransporter 2 inhibitors on the incidence of perioperative metabolic acidosis: A retrospective cohort study

Sodium-glucose cotransporter 2 inhibitor-associated perioperative ketoacidosis: a systematic review of case reports

The effect of preoperative sodium-glucose cotransporter 2 inhibitors on the incidence of perioperative metabolic acidosis: A retrospective cohort study

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