Coronary Artery DiseaseNCT05448521
Postoperative Lactate and Atrial Fibrillation After CABG
An observational study of Coronary Artery Disease and Atrial Fibrillation, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Atrial Fibrillation
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2022to 15 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Undergoing isolated CABG
- Age >18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Basaksehir Cam Sakura City Hospital
Istanbul
Zeki Temizturk, MD
About this study
Official title: Association of Postoperative Lactate Levels With Postoperative Atrial Fibrillation in Patients Undergoing Isolated Coronary Artery Bypass Graft Surgery
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.
- Conditions
- Coronary Artery Disease, Atrial Fibrillation
- Medical subject headings
- Coronary Artery Disease, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative atrial fibrillation
New-onset atrial fibrillation occurring in the immediate period after CABG
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start15 Aug 2022
- Primary completion15 Aug 2023 (estimated)
- Study completion15 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeki Temiztürk, Başakşehir Çam & Sakura City Hospital
- Investigators
- Ahmet Can Topcu, MD, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448521
- Sponsor's protocol ID
- KAEK/2021.12.289
- Status last verified
- Oct 2022
- First submitted
- 1 Jul 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28369234O'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.
PubMed 22813486Dobrev 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.
PubMed 30792496
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Postoperative Lactate Levels With Postoperative Atrial Fibrillation in Patients Undergoing Isolated Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT05448521
- Acronym / sponsor ID
- KAEK/2021.12.289
- Conditions
- Coronary Artery Disease, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Undergoing isolated CABG
- Age >18 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative atrial fibrillation
Time frame: 30 days
New-onset atrial fibrillation occurring in the immediate period after CABG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Background: PubMed 28369234Greenberg 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.
- Background: PubMed 22813486O'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.
- Background: PubMed 30792496Dobrev 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Can Topcu, MD principal investigator
Başakşehir Çam & Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Atrial Fibrillation, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeki Temizturk, MD (902129096000, zekitmztrk5806@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative atrial fibrillation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05448521, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.