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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04120012
Other study ID # 2019-8-20
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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