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Incidence of Post-operative Atrial Fibrillation Secondary to Abdominal Surgery

NCT04090905 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 466

Last updated 2022-05-27

No results posted yet for this study

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

Interventions

OTHER

Standard clinical monitoring

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

DIAGNOSTIC_TEST

Holter monitoring

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

Sponsors & Collaborators

  • Frederiksberg University Hospital

    lead OTHER

Principal Investigators

  • Christoffer V Madsen, MD · University Hospital Bispebjerg and Frederiksberg

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-13
Primary Completion
2021-10-01
Completion
2021-12-31

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04090905 on ClinicalTrials.gov