Development of Ketoacidosis During the Perioperative Period: an Observational Study 'The DKAP Study'
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Blood ketone difference
研究概览
简要总结
Rationale:
During perioperative period, prolonged starvation, surgical stress, acute complications (e.g. infection) and medication changes all promote ketone generation, therefore increasing the risk of ketoacidosis. At present, there is no literature concerning the ketone production in patients undergoing cardiac surgery, regardless of the diabetes status.
Objectives:
The objectives of this study are to explore the change in blood ketone level during the perioperative period in patients with and without diabetes, to observe the incidence of perioperative ketoacidosis, and to investigate therapy and outcome of patients with perioperative ketoacidosis.
详细描述
Study procedures On the first day of admission, all the patients scheduled for cardiac surgery with an on-pump procedure will be asked for a consent for anonymous using of their information. Patients giving permission will be screened for participation in this study, and those fulfil the inclusion/exclusion criteria will be included for further research.
Blood ketone will be measured with StatStrip Glucose/Ketone Meters (Nova biomedical, United Kingdom) using sample leftover from blood gas analysis. No extra blood draw is needed. The levels of ketones will be measured at four time points:
- Beginning of surgery;
- The moment the cardio-pulmonary bypass machine takes over the circulation.
- After the decoupling of the Cardio-pulmonary bypass machine
- At the end of surgery.
Diagnosis of ketoacidosis is based on criteria mentioned. Epidemiology characteristics and perioperative variables will be extracted from electronic medical records.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Blood ketone difference
时间窗: During surgery
The primary outcome in this study is the difference in blood ketone level before and after cardiac surgery.
次要结局
- Incidence of ketoacidosis(Post surgery up to three days)
- Difference in ketone development between patient with and without diabetes mellitus.(During Surgery)
研究者
Lars Ivar Pieter Snel
Clinical Research Physician
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)