Development of Ketoacidosis During the Perioperative Period: an Observational Study 'The DKAP Study' (NCT05225467) | Clinical Trial Compass
CompletedNot Applicable
Development of Ketoacidosis During the Perioperative Period: an Observational Study 'The DKAP Study'
Netherlands58 participantsStarted 2022-03-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Blood ketone difference
Timeframe: During surgery
Trial details
NCT IDNCT05225467
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)