Postoperative Incidence of Atrial Fibrillation Following Cardiac Surgery

NCT06855550 | Completed

• 1 other identifier: 2023PROCCA0043
• Study Type: observational
• Target: 435
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Postoperative atrial fibrillation is one of the most frequent complications in cardiac surgery, with an expected incidence of more than 50% following valve surgery. Hypomagnesemia is also likely to be observed in the postoperative period, and several studies have suggested that it could be related to the incidence of postoperative atrial fibrillation. In this study, via a prospective design and adjustment for multiple covariates, the investigators will seek to determine whether plasma magnesium levels are independently associated with the appearance of postoperative atrial fibrillation. Methods: An analytical design involving a concurrent cohort will be carried out in a high-complexity hospital with a cardiovascular focus. Serial postoperative plasma magnesium measurements will be included as independent variables in a logistic regression model to determine their association with atrial fibrillation after adjusting for multiple covariates.

Conditions

Atrial Fibrillation (AF); Hypomagnesemia; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative Atrial fibrilation

  Defined as irregular QRS without p wave during 30 seconds in a 12 derivations EKG.

  Measurement was performed first day after surgery up to 30 days postoperatively or discharge (whichever came first)

Secondary Outcomes (1)

• Mortality

  Measurement was performed first day after surgery up to 30 days postoperatively or discharge (whichever came first)

Study Arms (1)

Postoperative cardiac surgery

Patients who will undergo elective cardiac surgery of any kind will be included, except those with a history of preoperative atrial fibrillation, urgent/emergency surgery, or those who will undergo maze surgery (alone or in combination with other procedures). Magnesium levels will be measured immediately after surgery and every subsequent 12-24 hours during the stay in the intensive care unit. Each patient will be followed up, and morbidity and mortality will be recorded through in-hospital evaluation or up to 30 days postoperatively (whichever occurs first). Follow-up will be performed by a member of the research team who will be blinded to the postoperative magnesium levels. Preoperative evaluation, premedication, anesthetic/surgical technique, and postoperative care will conducted according to institutional protocols; no modifications of any kind will be made for the participants.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent cardiac surgery at Fundación Cardioinfantil-Instituto de Cardiología, from May 2015 to May 2016.

You may qualify if:

• Adults in postoperative cardiac surgery

You may not qualify if:

• Preoperative atrial fibrillation
• Without complete information regarding plasmatic magnesium postoperative measurements

Sponsors & Collaborators

• Fundación Cardioinfantil Instituto de Cardiología: lead

Study Sites (1)

Fundación Cardioinfantil-Instituto de Cardiología

Bogotá, Bogota D.C., 110131, Colombia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiovascular Critical Care

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 4, 2025
• Study Start: May 4, 2015
• Primary Completion: June 3, 2016
• Study Completion: December 12, 2022
• Last Updated: March 7, 2025

Record last verified: 2025-02

Locations

CO (1)