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CompletedNCT04120012Updated Jan 28, 2025

The Effect of Frailty to Perioperative Complications in the Elderly

An observational study in Fragility, Intraoperative Hypotension and Perioperative Complication, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-01-28.

Sponsored by Peking Union Medical College Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
166
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Fragility
  • Intraoperative Hypotension
  • Perioperative Complication

Keywords

  • Frailty
  • Intraoperative Hypotension
  • Perioperative Complication
  • Elderly
03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 166 is above the median of 84 across 294 observational studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
166 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Intraoperative

  2. 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.

    Time frame: Intraoperative

Secondary outcomes

  1. 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.

    Time frame: Within 30days after surgery

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Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, Beijing 100005, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04120012
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Oct 9, 2019
Start date
Nov 20, 2019
Primary completion
Apr 25, 2022
Completion
May 25, 2022
Last update
Jan 28, 2025

Study contacts

Li Xu, M.D.
principal investigator · Peking Union Medical College Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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