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

NCT05225467 | Completed

• 1 other identifier: DKAP2022
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Ketosis; Keto Acidosis; Ketoses, Metabolic; Ketosis, Diabetic; Peri-operative; Diabetes Mellitus

Keywords

Surgery; Ketones

Outcome Measures

Primary Outcomes (1)

• Blood ketone difference

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

  During surgery

Secondary Outcomes (2)

• Incidence of ketoacidosis

  Post surgery up to three days

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

  During Surgery

Other Outcomes (1)

• Other

  Post surgery up to three days

Study Arms (1)

Main group

All participants taking part in this study are subsequently categorized in this group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged eighteen years or older
• Scheduled for open heart surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam University Medical Centre

Amsterdam-Zuidoost, North Holland, 1105 AZ, Netherlands

Location

Related Publications (8)

• 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.

  PMID: 26610629 BACKGROUND

• 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.

  PMID: 32943440 BACKGROUND

• 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.

  PMID: 34631141 BACKGROUND

• 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.

  PMID: 31060732 BACKGROUND

• 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.

  PMID: 31756175 BACKGROUND

• 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.

  PMID: 27291355 BACKGROUND

• 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.

  PMID: 8301829 BACKGROUND

• 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.

  PMID: 29341404 BACKGROUND

MeSH Terms

Conditions

Ketosis; Diabetic Ketoacidosis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders

Study Officials

• Jeroen Hermanides, dr

  Amsterdam Univeristy medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Physician

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 4, 2022
• Study Start: March 15, 2022
• Primary Completion: March 17, 2023
• Study Completion: March 18, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

NL (1)