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

April 6, 2019 updated by: Andrea Szekely, Semmelweis University Heart and Vascular Center
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1122
        • Semmelweis University, Heart and Vascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive evaluable patients, 18 years old or older, admitted to Semmelweis University, Heart and Vascular Center for elective cardiac or vascular surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients undergoing vascular procedures
Including all non-interventional surgical procedures, excluding varix surgery
Patients undergoing cardiac procedures
Including all non-interventional surgical procedures, excluding HTX

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
The composite of in-hospital death from any cause.
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
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.
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
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.
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative cardiac arrythmias.
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative SIRS.
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
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.
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Evidence of clinically definite postoperative peripheral vascular insufficiency.
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
The need for reoperation due to bleeding.
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University Heart and Vascular Center

Investigators

  • Principal Investigator: Eniko Holndonner-Kirst, MD, Semmelweis University
  • Study Chair: János Gál, MD, PhD, Semmelweis University
  • Study Director: Andrea Székely, MD, PhD, Semmelweis University, Department of Anesthesiology and Intensive Therapy
  • Principal Investigator: Daniel J Lex, MD, Semmelweis University Heart and Vascular Center
  • Principal Investigator: Nikoletta Czobor, Semmelweis University
  • Principal Investigator: Peter Misnyovszki, Semmelweis University
  • Principal Investigator: Hanna Tihanyi, Semmelweis University
  • Principal Investigator: Kalatin Fink, MD, Semmelweis University
  • Study Chair: Béla Merkely, MD, PhD, DSc, Semmelweis University
  • Study Chair: László Entz, MD, PhD, Semmelweis University
  • Study Chair: Zoltán Szabolcs, MD, PhD, Semmelweis University
  • Study Chair: Erzsébet Paulovich, MD, Semmelweis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

August 14, 2014

First Submitted That Met QC Criteria

August 22, 2014

First Posted (Estimate)

August 25, 2014

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 6, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VSZÉK-FRAILTY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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