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

Semmelweis University Heart and Vascular Center1 site in 1 country300 target enrollmentJuly 2014

ConditionsIntellectual Frailty of Aging Cardiovascular Diseases Myocardial Infarction Vascular Diseases Heart; Dysfunction Postoperative, Cardiac Surgery

Overview

Phase: N/A
Intervention: Not specified
Conditions: Intellectual Frailty of Aging
Sponsor: Semmelweis University Heart and Vascular Center
Enrollment: 300
Locations: 1
Primary Endpoint: Length of hospital and intensive care unit stay.
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

July 2020

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Semmelweis University Heart and Vascular Center

Responsible Party

Principal Investigator

Andrea Szekely

Associate professor

Semmelweis University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Length of hospital and intensive care unit stay.

Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

Secondary Outcomes

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 acute kidney injury and the need for dialysis.(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.)