Development of Ketoacidosis During the Perioperative Period: an Observational Study 'The DKAP Study'

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Development of Ketoacidosis During the Perioperative Period: an Observational Study 'The DKAP Study'

Conditions
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Ketosis, Keto Acidosis, Ketoses, Metabolic, Ketosis, Diabetic, Peri-operative, Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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In order to be eligible to participate in this study, a subject must meet all of the following criteria: Inclusion Criteria Aged eighteen years or older Scheduled for open heart surgery Exclusion criteria Diagnosed with type 1 diabetes mellitus or latent auto-immune diabetes in adults Recently used sodium glucose transport co-enzyme 2 (SGLT-2i's) within 2 weeks before surgery) History of recurrent ketoacidosis (two times or more within three months) Emergency surgery (Suspected) pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main group<br>All participants taking part in this study are subsequently categorized in this group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood ketone difference | The primary outcome in this study is the difference in blood ketone level before and after cardiac surgery. | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ketoacidosis | The diagnosis criteria for Ketoacidosis are: 1) Beta-hydroxybutyrate (BHB) ≥3 mmol/L or significant ketonuria (≥ ++); 2) blood glucose over 11 mmol/L; and 3) bicarbonate below 15 mmol or arterial potential of hydrogen(pH) less than 7.3. | Post surgery up to three days | 
| Difference in ketone development between patient with and without diabetes mellitus. | Glucose management is compared between two groups to see if there is a potential difference. | During Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Ketones