Incidence of Post-operative Atrial Fibrillation Secondary to Abdominal Surgery

NCT04090905 | Completed

• 1 other identifier: H-19033464
• Study Type: observational
• Target: 466
• Locations: 1 country
• Sites: 1

Brief Summary

Background and purpose Post-operative AF (POAF) is considered a phenomenon rather than a definite diagnosis and the current clinical guidelines have no specific recommendations regarding its management. Few prospective studies have been performed in non-cardiac conditions and the consequences of POAF in patients without known heart disease are not well described. However, recent data suggest an association between POAF in relation to non-cardiac surgery and increased post-operative mortality and stroke. POAF in relation to abdominal surgery seems common (incidence: 8-18%); however, the true incidence is uncertain. The available studies are few, heterogeneous, and often methodologically inadequate. The study aims at reporting the incidence of atrial fibrillation (AF), and associated complications, in relation to abdominal surgery. Material and methods Designed as a prospective, single-centre, cohort study of consecutive adult patients undergoing acute\* abdominal surgery at the Department of Abdominal Surgery at Bispebjerg Hospital. Patients who are pregnant or where follow-up is not possible will be excluded. Patients will be examined pre-operatively by ECG and signal processed surface ECG (wavECG). A subset of patients admitted to the Department in the time interval of 7 AM to 11 PM$, will be offered heart rhythm monitoring from admission and until discharge (preferably ≥72 hours post-operatively). Additional follow-up will be based on a review of patient charts at discharge and one# month postoperatively. The primary endpoint is the occurrence/recurrence of AF. The study will include 400-500 patients of which an estimated 2/3 will wear heart rhythm monitoring corresponding to 264-330 patients. Perspective If more thorough heart rhythm monitoring of patients undergoing abdominal surgery leads to the identification of more patients with AF, routine continuous heart rhythm monitoring should be considered recommended in upcoming guidelines to prevent associated complications. Footnote(s): See 'Detailed Description' below.

Conditions

Atrial Fibrillation; Surgery--Complications

Keywords

post-operative atrial fibrillation; abdominal surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of clinically recognized peri- and post-operative atrial fibrillation

  Occurrence of clinically recognized POAF, defined as recognized by clinical staff and verified by a 12-lead electrocardiogram and adjudicated by Cardiology specialists.

  In-hospital, defined as occurring from termination of surgery and until discharge from the hospital. Assessed up to 7 days from surgery.

Secondary Outcomes (6)

• Incidence of peri- and post-operative atrial fibrillation by cardiac rhythm monitoring

  In-hospital, defined as occurring from termination of surgery and until discharge from the hospital. Assessed up to 7 days from surgery.

• Incidence of clinically recognized post-operative atrial fibrillation

  Out-of-hospital, defined as within 30 days from index surgery

• Incidence of clinical events after surgery

  In-hospital, defined as occurring from termination of surgery and until discharge from the hospital. Assessed up to 7 days from surgery.

• Incidence of clinical events after surgery

  Out-of-hospital, defined as within 30 days from index surgery

• Number of patients with abnormal p-wave indexes

  Before surgery

Study Arms (2)

Unselected cohort

Consecutive adult patients who were referred for acute abdominal surgery. Patients underwent standard observation in either a surgical ward (utilizing the National Early Warning Score) or the intensive care unit with continuous respiratory and circulatory monitoring.

Other: Standard clinical monitoring

Subgroup with Holter monitoring

Consecutive adult patients who were referred for acute abdominal surgery in the time interval 7 AM to 11 PM. Holter monitoring was applied on top of standard observation in either a surgical ward (utilizing the National Early Warning Score) or the intensive care unit with continuous respiratory and circulatory monitoring.

Other: Standard clinical monitoring; Diagnostic Test: Holter monitoring

Interventions

Standard clinical monitoring OTHER

Standard observation in either a surgical ward (utilizing the National Early Warning Score) or the intensive care unit with continuous respiratory and circulatory monitoring.

Subgroup with Holter monitoring; Unselected cohort

Holter monitoring DIAGNOSTIC_TEST

Cardiac rhythm monitoring before, during, and until hospital discharge (preferably ≥72 hours after abdominal surgery)

Subgroup with Holter monitoring

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients undergoing acute abdominal surgery at the Department of Abdominal Surgery at Bispebjerg Hospital (Copenhagen, Denmark)

You may qualify if:

• Acute abdominal surgery (non-oesophageal)
• Age ≥ 16 years

You may not qualify if:

• Pregnancy
• Follow-up not possible

Sponsors & Collaborators

• Frederiksberg University Hospital: lead

Study Sites (1)

Bispebjerg-Frederiksberg Hospital

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Christoffer V Madsen, MD

  University Hospital Bispebjerg and Frederiksberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 16, 2019
• Study Start: June 13, 2020
• Primary Completion: October 1, 2021
• Study Completion: December 31, 2021
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

DK (1)