NCT05448521

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

July 1, 2022

Last Update Submit

October 6, 2022

Conditions

Coronary Artery DiseaseAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Postoperative atrial fibrillation

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

    30 days

Study Arms (2)

Low lactate

Patients with a low lactate level defined by logistic regression analysis.

High lactate

Patients with a high lactate level defined by logistic regression analysis.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive adult patients undergoing isolated CABG during the study period in the Department of Cardiovascular Surgery at Basaksehir Cam Sakura City Hospital will be evaluated for possible enrollment.

You may qualify if:

  • Undergoing isolated CABG
  • Age \>18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basaksehir Cam Sakura City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

    PMID: 28369234BACKGROUND

  • 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. doi: 10.1177/0310057X1204000404.

    PMID: 22813486BACKGROUND

  • 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.

    PMID: 30792496BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseAtrial Fibrillation

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmet Can Topcu, MD

    Başakşehir Çam & Sakura City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeki Temizturk, MD

CONTACT

902129096000zekitmztrk5806@gmail.com

Ahmet Can Topcu, MD

CONTACT

902165001500ahmet.topcu@icloud.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 7, 2022

Study Start

August 15, 2022

Primary Completion

August 15, 2023

Study Completion

September 15, 2023

Last Updated

October 10, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)