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

Completed

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

• Registration Number: NCT05225467
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Timeline

• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-04
• Study Start: 2022-03-15
• Primary Completion: 2023-03-17
• Study Completion: 2023-03-18
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood ketone difference	During surgery	The primary outcome in this study is the difference in blood ketone level before and after cardiac surgery.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Amsterdam University Medical Centre; 🇳🇱 Amsterdam-Zuidoost, Noord-Holland, Netherlands