Postoperative Lactate and Atrial Fibrillation After CABG

• Sponsor: Basaksehir Cam & Sakura Şehir Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05448521
• Collaborator: (none)
• Enrollment: 250
• Anticipated Duration (Months): 13

Study Details

Study Description

Brief Summary

Postoperative atrial fibrillation (POAF) is associated with increased mortality and morbidity in patients undergoing isolated coronary artery bypass grafting (CABG). It has been estimated that 5-40% of CABG patients experience POAF. Advanced age, P wave abnormalities, left atrial dilation, emergency surgery, low left ventricle ejection fraction, low glomerular filtration rate and chronic obstructive pulmonary disease have been reported in the etiology. Predicting which patients would experience POAF following CABG is important since it would allow physicians to apply more focused prophylactic measures. Lactate is the final product of anaerobic glycolysis. Serum lactate level are increased in case of inadequate oxygen delivery to tissues. The investigators aim to assess whether serum lactate levels measured early in the postoperative period could be used as a predictive marker of POAF in adults undergoing isolated CABG.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Atrial Fibrillation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 250 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Association of Postoperative Lactate Levels With Postoperative Atrial Fibrillation in Patients Undergoing Isolated Coronary Artery Bypass Graft Surgery
• Anticipated Study Start Date: Aug 15, 2022
• Anticipated Primary Completion Date: Aug 15, 2023
• Anticipated Study Completion Date: Sep 15, 2023

Outcome Measures

Primary Outcome Measures

1. Postoperative atrial fibrillation [30 days]

   New-onset atrial fibrillation occurring in the immediate period after CABG

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Undergoing isolated CABG

• Age >18 years

Exclusion Criteria:

• Age <18 years

• Pregnancy

• History of paroxysmal atrial fibrillation prior to surgery

• Undergoing concomitant procedures (e.g., CABG + valve surgery)

• Any preoperative cardiac rhythm other than normal sinus rhythm

• More than mild cardiac valve stenosis or insufficiency

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Basaksehir Cam & Sakura Şehir Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Dobrev D, Aguilar M, Heijman J, Guichard JB, Nattel S. Postoperative atrial fibrillation: mechanisms, manifestations and management. Nat Rev Cardiol. 2019 Jul;16(7):417-436. doi: 10.1038/s41569-019-0166-5. Review.
• Greenberg JW, Lancaster TS, Schuessler RB, Melby SJ. Postoperative atrial fibrillation following cardiac surgery: a persistent complication. Eur J Cardiothorac Surg. 2017 Oct 1;52(4):665-672. doi: 10.1093/ejcts/ezx039. Review.
• O'Connor E, Fraser JF. The interpretation of perioperative lactate abnormalities in patients undergoing cardiac surgery. Anaesth Intensive Care. 2012 Jul;40(4):598-603. Review.

• Responsible Party: Zeki Temiztürk, Principal Investigator, Basaksehir Cam & Sakura Şehir Hospital
• ClinicalTrials.gov Identifier: NCT05448521
• Other Study ID Numbers: KAEK/2021.12.289
• First Posted: Jul 7, 2022
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation; Coronary Artery Disease

Study Results

No Results Posted as of Jul 11, 2022