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

Diabetes Mellitus Clinical Trial

— DKAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05225467
• Other study ID #: DKAP2022
• Status: Completed
• Start date: March 15, 2022
• Est. completion date: March 18, 2023

Study information

• Verified date: July 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 18, 2023
• Est. primary completion date: March 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Diabetes Mellitus
• Diabetic Ketoacidosis
• Ketoses, Metabolic
• Ketosis
• Ketosis, Diabetic
• Peri-operative

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Centre	Amsterdam-Zuidoost	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other	Incidence of hypoglycaemia	Post surgery up to three days
Primary	Blood ketone difference	The primary outcome in this study is the difference in blood ketone level before and after cardiac surgery.	During surgery
Secondary	Incidence of ketoacidosis	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
Secondary	Difference in ketone development between patient with and without diabetes mellitus.	Glucose management is compared between two groups to see if there is a potential difference.	During Surgery