The Effect of Frailty to Perioperative Complications in the Elderly

Perioperative Complication Clinical Trial

Official title:

The Effect of Frailty to Intraoperative Hemodynamic Instability and Perioperative Complications in the Elderly: a Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04120012
• Other study ID #: 2019-8-20
• Status: Recruiting
• Start date: November 20, 2019
• Est. completion date: September 2022

Study information

• Verified date: March 2022
• Source: Peking Union Medical College Hospital
• Contact: Li Xu, M.D.
• Phone: +86 13681299622
• Email: pumchxuli[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

With the progression of population aging, the number of elderly patients undergoing surgery is increasing as well. However, as the condition of health differs greatly between individual elderly patients even of the same age, it is a necessity to evaluate elderly patients thoroughly and individually for better management of perioperative care.

Frailty is a condition in which patients are impaired at physical reserve and homeostatic control. Frail elderly people are at higher risk of morbidity and mortality after exposure to a stressor. Frail patients are at higher risk of perioperative complications and longer hospital stay. However, there has been no standard criteria or tool to evaluate frailty in the elderly. Neither has there been enough evidence explaining the mechanism between frailty and increased perioperative complications. Therefore, in this study we aim to discover the relationship between frailty and intraoperative hemodynamic instability, as well as perioperative complications in the elderly patients, hoping to find an adequate and practical model for preoperative assessment in the elderly hopefully for better perioperative outcome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• age=65 years

• elective major non-cardiac surgery

• general anesthesia

• American Society of Anesthesiologists(ASA) grade I,II,III

• study protocol fully understood by the patients, written consent obtained

Exclusion Criteria:

• emergency surgery

• in active state of infection or inflammation

• chronic kidney disease(CKD) stage 5

• having conditions that would interfere accurate measurement of upper extremity blood pressure (e.g. subclavian artery stenosis)

• having conditions that would interfere assessment of frailty assessment (e.g. mental disorder, hearing disorder)

• study protocol not fully understood, no written consent obtained

Related Conditions & MeSH terms

• Fragility
• Frailty
• Hypotension
• Intraoperative Hypotension
• Perioperative Complication

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of intraoperative hypotension	Intraoperative hypotension includes post induction hypotension(PIH), early intraoperative hypotension(eIOH) and late intraoperative hypotension(lIOH). Hypotension is defined as a systolic blood pressure less than 90mmHg or a relative decrease more than 30% compared to baseline blood pressure, or mean arterial pressure less than 65mmHg or a decrease more than 30% compared to baseline. PIH is defined as a hypotension within 20 minutes after anesthesia induction, or before surgical incision. eIOH is defined as hypotension within 30 minutes after the start of surgery. lIOH is defined as hypotension that happen 30 minutes after the start of surgery until the end of surgery.	Intraoperative
Primary	Incidence of intraoperative hemodynamic instability	Intraoperative hemodynamic instability is defined as a definite change of systolic blood pressure, or mean arterial pressure, or diastolic pressure, or pulse pressure more than 15% or the need for vasoactive agents.	Intraoperative
Secondary	Incidence of postoperative complications	Postoperative complications will be recorded according to medical records and laboratory results within 30 days after surgery according to Clavien-Dindo classification of surgical complications. Incidence of each grade will be calculated as outcome. Postoperative acute kidney injury will be assessed by analysis of urinary and serum biomarkers before and after surgery.	Within 30days after surgery