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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT05225467

DKAP2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

58 participants in 1 patient group

Main group

Description:

All participants taking part in this study are subsequently categorized in this group