Diabetes Mellitus, Keto Acidosis, Ketoses, Metabolic, Ketosis, Ketosis, Diabetic, Peri-operative
Conditions
Keywords
Surgery, Ketones
Brief summary
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
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: 1. Beginning of surgery; 2. The moment the cardio-pulmonary bypass machine takes over the circulation. 3. After the decoupling of the Cardio-pulmonary bypass machine 4. 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.
Interventions
None listed
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood ketone difference | During surgery | The primary outcome in this study is the difference in blood ketone level before and after cardiac surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ketoacidosis | Post surgery up to three days | 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. |
| Difference in ketone development between patient with and without diabetes mellitus. | During Surgery | Glucose management is compared between two groups to see if there is a potential difference. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Other | Post surgery up to three days | Incidence of hypoglycaemia |
Countries
Netherlands
Outcome results
None listed