Clinical trial NCT05225467: Development of Ketoacidosis During the Perioperative Period: an Observational Study 'The DKAP Study'
Official title: Development of Ketoacidosis During the Perioperative Period: an Observational Study 'The DKAP Study'
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ketosis
Keto Acidosis
Ketoses, Metabolic
Ketosis, Diabetic
Peri-operative
Diabetes Mellitus
Keywords: Surgery
Ketones
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Blood ketone difference
timeFrame: During surgery
Secondary outcomes:
measure: Incidence of ketoacidosis
timeFrame: Post surgery up to three days
measure: Difference in ketone development between patient with and without diabetes mellitus.
timeFrame: During Surgery
Other outcomes:
measure: Other
timeFrame: Post surgery up to three days
Locations:
city: Amsterdam-Zuidoost
country: Netherlands
facility: Amsterdam University Medical Centre
state: Noord-Holland
Study officials:
affiliation: Amsterdam Univeristy medical Center
name: Jeroen Hermanides, dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vetter TR, Jones KA. Perioperative Surgical Home: Perspective II. Anesthesiol Clin. 2015 Dec;33(4):771-84. doi: 10.1016/j.anclin.2015.07.002.
citation: Meyer EJ, Mignone E, Hade A, Thiruvenkatarajan V, Bryant RV, Jesudason D. Periprocedural Euglycemic Diabetic Ketoacidosis Associated With Sodium-Glucose Cotransporter 2 Inhibitor Therapy During Colonoscopy. Diabetes Care. 2020 Nov;43(11):e181-e184. doi: 10.2337/dc20-1244. Epub 2020 Sep 17. No abstract available.
citation: Anderson JC, Mattar SG, Greenway FL, Lindquist RJ. Measuring ketone bodies for the monitoring of pathologic and therapeutic ketosis. Obes Sci Pract. 2021 May 4;7(5):646-656. doi: 10.1002/osp4.516. eCollection 2021 Oct.
citation: Thiruvenkatarajan V, Meyer EJ, Nanjappa N, Van Wijk RM, Jesudason D. Perioperative diabetic ketoacidosis associated with sodium-glucose co-transporter-2 inhibitors: a systematic review. Br J Anaesth. 2019 Jul;123(1):27-36. doi: 10.1016/j.bja.2019.03.028. Epub 2019 May 3.
citation: Blanco JC, Khatri A, Kifayat A, Cho R, Aronow WS. Starvation Ketoacidosis due to the Ketogenic Diet and Prolonged Fasting - A Possibly Dangerous Diet Trend. Am J Case Rep. 2019 Nov 22;20:1728-1731. doi: 10.12659/AJCR.917226.
citation: Dennhardt N, Beck C, Huber D, Sander B, Boehne M, Boethig D, Leffler A, Sumpelmann R. Optimized preoperative fasting times decrease ketone body concentration and stabilize mean arterial blood pressure during induction of anesthesia in children younger than 36 months: a prospective observational cohort study. Paediatr Anaesth. 2016 Aug;26(8):838-43. doi: 10.1111/pan.12943. Epub 2016 Jun 13.
citation: Ohkawa H, Iwakawa T, Ohtomo N, Kitayama M, Miyahara A, Ishihara H, Matsuki A. [Clinical study on intraoperative hyperketonemia in non-diabetic surgical patients under general anesthesia]. Masui. 1993 Dec;42(12):1803-7. Japanese.
citation: Polidori D, Iijima H, Goda M, Maruyama N, Inagaki N, Crawford PA. Intra- and inter-subject variability for increases in serum ketone bodies in patients with type 2 diabetes treated with the sodium glucose co-transporter 2 inhibitor canagliflozin. Diabetes Obes Metab. 2018 May;20(5):1321-1326. doi: 10.1111/dom.13224. Epub 2018 Feb 14.