Clinical trial NCT02224222: Assessment of Frailty as a Risk Factor for Cardiac and Vascular Surgery
Official title: Assessment of Frailty as a Risk Factor for Cardiac and Vascular Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intellectual Frailty of Aging
Cardiovascular Diseases
Myocardial Infarction
Vascular Diseases
Heart; Dysfunction Postoperative, Cardiac Surgery
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
First posted: 2014-08-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Length of hospital and intensive care unit stay.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Secondary outcomes:
measure: The composite of in-hospital death from any cause.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
measure: Evidence of clinically definite postoperative acute kidney injury and the need for dialysis.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
measure: Evidence of clinically definite postoperative low cardiac output syndrome.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
measure: Evidence of clinically definite postoperative cardiac arrythmias.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
measure: Evidence of clinically definite postoperative SIRS.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
measure: Evidence of clinically definite postoperative acute lung injury and the need for mechanical ventilation.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
measure: Evidence of clinically definite postoperative peripheral vascular insufficiency.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
measure: The need for reoperation due to bleeding.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Heart and Vascular Center
Study officials:
affiliation: Semmelweis University, Department of Anesthesiology and Intensive Therapy
name: Andrea Székely, MD, PhD
role: STUDY_DIRECTOR
affiliation: Semmelweis University Heart and Vascular Center
name: Daniel J Lex, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis University
name: Nikoletta Czobor
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis University
name: Peter Misnyovszki
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis University
name: Hanna Tihanyi
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis University
name: Kalatin Fink, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis University
name: Béla Merkely, MD, PhD, DSc
role: STUDY_CHAIR
affiliation: Semmelweis University
name: László Entz, MD, PhD
role: STUDY_CHAIR
affiliation: Semmelweis University
name: Zoltán Szabolcs, MD, PhD
role: STUDY_CHAIR
affiliation: Semmelweis University
name: János Gál, MD, PhD
role: STUDY_CHAIR
affiliation: Semmelweis University
name: Erzsébet Paulovich, MD
role: STUDY_CHAIR
affiliation: Semmelweis University
name: Eniko Holndonner-Kirst, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.