Skip to main content
OpenTrials
Completed

NCT Number: NCT05225467

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ketosis Acid-Base Imbalance Acidosis Diabetes Complications Diabetes Mellitus Diabetic Ketoacidosis Endocrine System Diseases Glucose Metabolism Disorders Keto Acidosis Ketoses, Metabolic Ketosis, Diabetic Metabolic Diseases Nutritional and Metabolic Diseases Peri-operative

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam University Medical Centre

Amsterdam-Zuidoost, North Holland, 1105 AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Blood ketone difference

    Time frame: During surgery

    The primary outcome in this study is the difference in blood ketone level before and after cardiac surgery.

Secondary outcomes

  1. Incidence of ketoacidosis

    Time frame: 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.

  2. Difference in ketone development between patient with and without diabetes mellitus.

    Time frame: During Surgery

    Glucose management is compared between two groups to see if there is a potential difference.

Other outcomes

  1. Other

    Time frame: Post surgery up to three days

    Incidence of hypoglycaemia

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: DKAP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 4, 2022
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.