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

July 19, 2023 updated by: Lars Ivar Pieter Snel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam-Zuidoost, Noord-Holland, Netherlands, 1105 AZ
        • Amsterdam University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients scheduled for cardiac surgery with an on-pump procedure are eligible for inclusion. A total of 54 subjects will be enrolled.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Main group
All participants taking part in this study are subsequently categorized in this group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post surgery up to three days
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.
During Surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other
Time Frame: Post surgery up to three days
Incidence of hypoglycaemia
Post surgery up to three days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Jeroen Hermanides, dr, Amsterdam Univeristy Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

March 17, 2023

Study Completion (Actual)

March 18, 2023

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

February 1, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DKAP2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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