Frailty
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Volunteers undergoing elective cardiac surgery for myocardial revascularization or to correct heart valve diseases with cardiopulmonary bypass; over 18 years old; all genders; all ethnicities
Exclusion criteria
Exclusion criteria: Emergency surgery; other associated cardiovascular procedure; acute myocardial infarction less than 30 days before operation; unstable angina; orthopedic or neurologic disorders that prevented or made it difficult to perform the functional tests; functional class IV of the NYHA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcomes 1: it was expected to find frailty in patients who were candidates for cardiac operations, even if they were not elderly, based on our previous studies;Expected outcomes 2: it was expected that a comprehensive assessment of frailty could improve the determination of frailty, especially in non-elderly people;Expected outcomes 3: it was expected that frailty would be associated with higher postoperative hospital mortality;Expected outcomes 4: it was expected that telomere length would be shorter in patients considered frail and that shorter telomere length could be associated with postoperative mortality;Outcome 1: It was observed that 24.5% of patients were considered non-frail, 58.2% were considered pre-frail, and 17.3% were frail according to the Fried phenotype. The mean age of those classified as non-frail, pre-frail, and frail was 55.9 ± 11.8 years, 57.3 ± 12.7 years, and 61.9 ± 9.1 years, respectively. However, 52.6% of those considered frail by the Fried phenotype were under 60 years of age;Outcome 2: Cluster analysis using the Hierarchical method, based on comprehensive frailty assessment parameters, revealed two clusters, with 65 patients allocated to Cluster 1 and 45 to Cluster 2. Cluster 1 included 100% of the patients classified as frail by Fried’s criteria, 61% of the pre-frail, and only 26% of those considered non-frail by the Fried phenotype (p < 0.001). The key parameters from the extended assessment that determined cluster formation were preoperative hemoglobin count, final Patient Health Questionnaire score, Mini Nutritional Assessment, Duke Activity Status Index, as well as the average 5-meter walk test and handgrip strength (p < 0.001). The proportion of patients aged 60 or older was not significantly different between clusters (55.4% in Cluster 1 and 46.7% in Cluster 2, p = 0.439);Outcome 3: Hospital mortality was observed to be 10% for valve operations and 7% for coronary artery bypass grafting (p = 0.739). Hospital mortality w | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected secondary outcome: it was expected that in addition to postoperative hospital mortality, telomere fragility, and length could be associated with postoperative morbidity.;Secondary Outcome: it was found that, except for invasive mechanical ventilation time between non-frail and pre-frail patients (p=0.028), there were no significant differences in postoperative outcomes among the different frailty phenotypes according to Fried. When analyzed by cluster grouping, patients in Cluster 1—who had shorter telomere length, worse performance in the comprehensive frailty assessment, and consisted of 100% of frail patients, 61% of pre-frail, and only 26% of those considered non-frail by the Fried phenotype—had significantly higher rates of invasive mechanical ventilation time (p=0.031), infections (p=0.001), renal dysfunction (p=0.008), and need for inotropes/vasopressors (p<0.001) postoperatively compared to Cluster 2 | — |
Countries
Brazil
Contacts
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo