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

NCT02224222 | Unknown

• 1 other identifier: VSZÉK-FRAILTY
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Semmelweis University Heart and Vascular Center: lead

Study Sites (1)

Semmelweis University, Heart and Vascular Center

Budapest, 1122, Hungary

Location

Related Publications (2)

• Toth K, Szabo A, Nagy A, Szabo D, Szecsi B, Eke C, Sandor A, Susanszky E, Holndonner-Kirst E, Merkely B, Gal J, Szekely A. Preoperative nutritional state is associated with mid- and long-term mortality after cardiac surgery. Ann Palliat Med. 2021 Nov;10(11):11333-11347. doi: 10.21037/apm-21-1015. Epub 2021 Sep 29.

  PMID: 34670385 DERIVED

• Szabo A, Toth K, Nagy A, Domokos D, Czobor N, Eke C, Sandor A, Merkely B, Susanszky E, Gal J, Szekely A. The effect of cognitive dysfunction on mid- and long-term mortality after vascular surgery. BMC Geriatr. 2021 Jan 13;21(1):46. doi: 10.1186/s12877-020-01994-x.

  PMID: 33441102 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Myocardial Infarction; Vascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Andrea Székely, MD, PhD

  Semmelweis University, Department of Anesthesiology and Intensive Therapy

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

• 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

• János Gál, MD, PhD

  Semmelweis University

  STUDY CHAIR

• Erzsébet Paulovich, MD

  Semmelweis University

  STUDY CHAIR

• Eniko Holndonner-Kirst, MD

  Semmelweis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 25, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 9, 2019

Record last verified: 2019-04

Locations

HU (1)