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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Semmelweis University Heart and Vascular Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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