Assessment of Frailty as a Risk Factor for Cardiac and Vascular Surgery

• Conditions: Intellectual Frailty of Aging; Cardiovascular Diseases; Myocardial Infarction; Vascular Diseases; Heart; Dysfunction Postoperative, Cardiac Surgery

• Registration Number: NCT02224222
• Lead Sponsor: Semmelweis University Heart and Vascular Center

Brief Summary

The purpose of this study is to assess the impact of frailty as a multidimensional risk factor on the outcomes of adult cardiac and vascular surgery. For the purpose of defining patient frailty a multimodal questionnaire has been developed including measurement of psychological, socioeconomical, neurological and behavioral aspects. This study also features an investigation of the possible relationship between sudden regional weather changes, individual meteorological susceptibility of the patients and the outcomes of adult cardiac and vascular surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-22
• Study First Posted: 2014-08-25
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-06
• Last Update Posted: 2019-04-09
• Primary Completion: 2020-04
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients, 18 years or older, admitted to the hospital for elective cardiac or vascular surgery.

Exclusion Criteria

• Not willing to participate.
• Pregnant women.
• During active psychiatric hospital care.
• Patients with defined legal incapability or limited capability.
• Congenital or acquired speech impediment and locomotion disability of any kind.
• Non-evaluable patient due to communication problems and insufficient clinical information for the judgement of frailty (CFS).
• Patients admitted solely for elective surgery of the varices of the lower extremities.
• Patients with a transplanted heart.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Length of hospital and intensive care unit stay.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

Secondary Outcome Measures

Name	Time	Method
Evidence of clinically definite postoperative acute kidney injury and the need for dialysis.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
The composite of in-hospital death from any cause.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative low cardiac output syndrome.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative cardiac arrythmias.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative SIRS.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative acute lung injury and the need for mechanical ventilation.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative peripheral vascular insufficiency.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
The need for reoperation due to bleeding.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

Trial Locations

Locations (1)

Semmelweis University, Heart and Vascular Center; 🇭🇺 Budapest, Hungary