NCT06838507尚未招募不适用
Incidence, Characterisation and Outcome-relevance of Perioperative SGLT2 Inhibitor Associated Ketoacidosis - a Multicentre Prospective Cohort Study
Heinrich-Heine University, Duesseldorf1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2025年4月最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Number of patients with postoperative ketoacidosis
研究概览
简要总结
The goal of this observational study is to generate data on the incidence and outcome-relevance of sodium-glucose cotransporter 2 (SGLT2) inhibitor associated ketoacidosis in adult patients with regular intake of any SGLT2 inhibitor within the last three months that are undergoing in-patient surgery. Further, it will describe strategies in current clinical practice to prevent and manage SGLT2 inhibitor associated ketoacidosis. The specific aims of this study are:
- To assess the incidence of SGLT2 inhibitor associated ketoacidosis in surgical patients
- To characterise fasting times in patients with SGLT2 inhibitor associated ketoacidosis
- To describe the management of SGLT2 inhibitor associated ketoacidosis in current clinical practice
- To assess the outcome impact of SGLT2 inhibitor associated ketoacidosis
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prescription and regular intakte of any SGLT2 inhibitor within the last three months (regardless if SGLT2 inhibitor was discontinued preoperatively or not)
- •Surgical procedure
- •At least one overnight stay in the hospital following surgery
- •Age >= 18 years
排除标准
- •Unwilling and/or unable to consent
- •Outpatient surgery
结局指标
主要结局
Number of patients with postoperative ketoacidosis
时间窗: From the immediate postoperative period to the first postoperative morning
Ketoacidosis will be defined as by the American Diabetes Association: * pH \<= 7,30 * Serum bicarbonate \<= 18 mmol/l * Serum and/or urine ketones positive
次要结局
- Composite of postoperative complications(From enrollment to the end of follow up at 30 days after discharge)
- Single postoperative complication(From enrollment to the end of follow up at 30 days after discharge)
- Acute kidney injury(From enrollment to the end of follow up at 30 days after discharge)
- Length of stay in-hospital(From enrollment to discharge (in-hospital) at approximately four days after surgery)
- Length of stay on intensive care unit(From entering the intensive care unit to discharge to the normal ward at approximately 2 days after surgery)
- Length of stay in the recovery room(From entering the recovery room to discharge to the normal ward at approximately one hour after surgery)
研究者
研究点 (1)
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