FragilityNCT04120012
The Effect of Frailty to Perioperative Complications in the Elderly
An observational study of Fragility and Intraoperative Hypotension, run by Peking Union Medical College Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fragility, Intraoperative Hypotension, Perioperative Complication
- How many people
- 166 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2019to 25 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
About this study
Official title: The Effect of Frailty to Intraoperative Hemodynamic Instability and Perioperative Complications in the Elderly: a Prospective Observational Study
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.
- Keywords
- Frailty, Intraoperative Hypotension, Perioperative Complication, Elderly
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Within 30days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start20 Nov 2019
- Primary completion25 Apr 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FragilityStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Xu, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120012
- Sponsor's protocol ID
- 2019-8-20
- Status last verified
- May 2022
- First submitted
- 7 Oct 2019
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Frailty to Intraoperative Hemodynamic Instability and Perioperative Complications in the Elderly: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04120012
- Acronym / sponsor ID
- 2019-8-20
- Keywords
- Frailty, Intraoperative Hypotension, Perioperative Complication, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of intraoperative hypotension
Time frame: Intraoperative
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.
Incidence of intraoperative hemodynamic instability
Time frame: Intraoperative
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.
1 secondary outcome
Incidence of postoperative complications
Time frame: Within 30days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Xu, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fragility and Intraoperative Hypotension, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intraoperative hypotension (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.