Pre-frailty and Rehospitalization in Cardiac Surgery

Coronary Artery Disease Clinical Trial

Official title:

Pre-frailty Status Increases the Risk of Rehospitalization and Mortality in Patients After Cardiac Surgery Without Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03949439
• Other study ID #: 2.352.465
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: May 2019
• Source: Instituto Dante Pazzanese de Cardiologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background: It has been demonstrated that pre-frailty has more adverse outcomes after cardiac surgery, however, data on prognosis and long-term evolution in pre-frailty patients after cardiac surgery without postoperative complications are still scarce. Design: To evaluate the impact of pre-frailty on functional survival in patients after cardiac surgery without complications.

Description:

A three-year retrospective study based on a physiotherapy database was conducted, and a sample of 453 patients over 65 years of age was enrolled. All of them had an established diagnosis of cardiovascular disease (myocardial infarction, valve regurgitation or stenosis) determined by previous electrocardiogram and/or Doppler echocardiography, and all had surgical interventions (coronary artery bypass [CAB], valve replacement or valve repair). Patients with prior neurological/muscular disease (previous stroke or muscular dystrophies), cognitive impairment resulting from previous injury, frailty score ≥ 5, non-elective/emergency surgery procedures or incomplete data were excluded.

According to the hospital protocol, frailty was assessed by the Clinical Frailty Score (CFS) 24 hours before the scheduled elective surgery. We assigned patients into two groups based on this score: non-frail (frailty score 1~3) and pre-frail (frailty score 4) according to their CFS.

If patients experienced adverse cardiovascular events—both during surgery or at the ICU— such as stroke, infection, prolonged mechanical ventilation time of more than 24 hrs, ICU stay of more than 48 hrs or in-hospital death, they were excluded. We decided to exclude these patients as our objective was to evaluate patients without any surgical complications as our group recently had demonstrated that pre-frail patients had worse outcomes after cardiac surgery in a short period of time.

All included patients were analysed for 3 years using data from the hospital and physiotherapy database, which included medical appointments every 6 months after hospital discharge and major adverse cardiovascular events (atrial fibrillation, pneumonia, pleural effusion, acute myocardial infarction, heart failure, stroke and death).

This retrospective study was approved by the Institutional Ethics Committee (number 2.352.465).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: July 30, 2018
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• established diagnosis of cardiovascular disease (myocardial infarction, valve regurgitation or stenosis) determined by previous electrocardiogram and/or Doppler echocardiography, and all had surgical interventions (coronary artery bypass [CAB], valve replacement or valve repair).

Exclusion Criteria:

• neurological/muscular disease (previous stroke or muscular dystrophies), cognitive impairment resulting from previous injury, frailty score = 5, non-elective/emergency surgery procedures or incomplete data

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Frailty
• Frailty Syndrome
• Myocardial Ischemia
• Surgery--Complications
• Valve Anomalies

Intervention

Procedure:
• Elective Cardiac Surgery
Surgical interventions (coronary artery bypass [CAB], valve replacement or valve repair).

Locations

Country	Name	City	State
Brazil	Dante Pazzanese Institute of Cardiology	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Dante Pazzanese de Cardiologia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Outcome	atrial fibrillation, pneumonia, pleural effusion, acute myocardial infarction, heart failure, stroke and death	3 years after hospital discharge