The Effect of Frailty to Perioperative Complications in the Elderly

NCT04120012 | Completed

• 1 other identifier: 2019-8-20
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fragility; Intraoperative Hypotension; Perioperative Complication

Keywords

Frailty; Intraoperative Hypotension; Perioperative Complication; Elderly

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Incidence of postoperative complications

  Within 30days after surgery

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study intend to include elderly patients (≥65years) who undergoes elective major non-cardiac surgery who can cooperate with upper extremity blood pressure measurement and frailty assessment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and urine samples will be collected from patients.

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Xu, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 9, 2019
• Study Start: November 20, 2019
• Primary Completion: April 25, 2022
• Study Completion: May 25, 2022
• Last Updated: January 28, 2025

Record last verified: 2022-05

Locations

CN (1)