To Investigate the Mortality of the Frailty PatientsNCT03792373
Hospital Ederly Life Program for Surgical Patients
An observational study of To Investigate the Mortality of the Frailty Patients, run by Zhongda Hospital at 1 site in China.
Trial summary
Frailty is the clinically recognizable medical condition, also called syndrome or phenotype, that is, the result of processes leading to an increased vulnerability for serious deteriorations in health and the diminished ability to cope with physical stressors. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- To Investigate the Mortality of the Frailty Patients
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 30 Dec 2019
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: ≥65 years
Who may be able to join
- elective noncardiac surgery
Who cannot join
- patients who don't cooperate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital
Nanjing, Jiangsu, 210009
Yang Jian-jun, 13357739238, yjyangjj@126.com
About this study
Official title: Effects of Frailty on Outcomes After Elective Noncardiac Surgery -a Prospective Cohort Study
Frailty is the clinically recognizable medical condition, also called syndrome or phenotype, that is, the result of processes leading to an increased vulnerability for serious deteriorations in health and the diminished ability to cope with physical stressors. Recently, frailty has emerged as a significant risk factor for adverse postoperative outcomes. It is related to declines in energy, strength, and function as well as to an increased inflammatory state, including elevated levels of interleukin 6 (IL-6), C-reactive protein (CRP), and anelevated white blood cell count . Frailty, as defined Frailty, as defined in the landmark paper by Fried, included at least three of five of the following criteria: unintentional loss of weight, low physical activity, low energy, low grip strength, and a slowed walking speed. Since then, various frailty scoring lists have been designed to optimize the predictive value. One of these is the Edmonton Frail Scale (EFS), an instrument that can be assessed quickly, using only a simple questionnaire which usually does not require more than five minutes to be completed and which covers most domains of functioning, making it easy and fast to get a reliable impression of the degree of frailty.The aim of this study was to determine which factors,with emphasis on frailty, significantly influence postoperative outcome after elective noncardiac surgery as measured by the Comprehensive Complication Index (CCI).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| frailty | Not described | |
| nonfrailty | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
one-year mortality
To investigate the one-year mortality of the frailty patients
Measured: 2019.02-2020.02
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start1 Dec 2018
- Primary completion30 May 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for To Investigate the Mortality of the Frailty PatientsStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-jun Yang, Zhongda Hospital
- Investigators
- Gaojun Teng, PhD, Study chair, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792373
- Sponsor's protocol ID
- HELP
- Status last verified
- Jan 2019
- First submitted
- 25 Dec 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shi JY, Gao DP, Chen R, Hu XY, Zhu LY, Zhang Y, Li Q, Mao QH, Ji MH, Fan D, Liu QR. Leveraging data-driven machine learning: From explainable risk prediction to hierarchical clustering-based subtypes of postoperative delirium in a prospective non-cardiac surgery cohort. J Clin Anesth. 2025 Nov;107:112006. doi: 10.1016/j.jclinane.2025.112006. Epub 2025 Sep 18.
PubMed 40972266Mao M, Wang LY, Zhu LY, Wang F, Ding Y, Tong JH, Sun J, Sun Q, Ji MH. Higher serum PGE2 is a predicative biomarker for postoperative delirium following elective orthopedic surgery in elderly patients. BMC Geriatr. 2022 Aug 19;22(1):685. doi: 10.1186/s12877-022-03367-y.
PubMed 35982410
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Frailty on Outcomes After Elective Noncardiac Surgery -a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03792373
- Acronym / sponsor ID
- HELP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 3 Jan 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.
Frailty is the clinically recognizable medical condition, also called syndrome or phenotype, that is, the result of processes leading to an increased vulnerability for serious deteriorations in health and the diminished ability to cope with physical stressors. Recently, frailty has emerged as a significant risk factor for adverse postoperative outcomes. It is related to declines in energy, strength, and function as well as to an increased inflammatory state, including elevated levels of interleukin 6 (IL-6), C-reactive protein (CRP), and anelevated white blood cell count . Frailty, as defined Frailty, as defined in the landmark paper by Fried, included at least three of five of the following criteria: unintentional loss of weight, low physical activity, low energy, low grip strength, and a slowed walking speed. Since then, various frailty scoring lists have been designed to optimize the predictive value. One of these is the Edmonton Frail Scale (EFS), an instrument that can be assessed quickly, using only a simple questionnaire which usually does not require more than five minutes to be completed and which covers most domains of functioning, making it easy and fast to get a reliable impression of the degree of frailty.The aim of this study was to determine which factors,with emphasis on frailty, significantly influence postoperative outcome after elective noncardiac surgery as measured by the Comprehensive Complication Index (CCI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| frailty | – | – |
| nonfrailty | – | – |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- ≥65 years
Key inclusion criteria (1 listed)
- elective noncardiac surgery
Key exclusion criteria (1 listed)
- patients who don't cooperate
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
one-year mortality
Time frame: 2019.02-2020.02
To investigate the one-year mortality of the frailty patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Derived from this study: PubMed 40972266Shi JY, Gao DP, Chen R, Hu XY, Zhu LY, Zhang Y, Li Q, Mao QH, Ji MH, Fan D, Liu QR. Leveraging data-driven machine learning: From explainable risk prediction to hierarchical clustering-based subtypes of postoperative delirium in a prospective non-cardiac surgery cohort. J Clin Anesth. 2025 Nov;107:112006. doi: 10.1016/j.jclinane.2025.112006. Epub 2025 Sep 18.
- Derived from this study: PubMed 35982410Mao M, Wang LY, Zhu LY, Wang F, Ding Y, Tong JH, Sun J, Sun Q, Ji MH. Higher serum PGE2 is a predicative biomarker for postoperative delirium following elective orthopedic surgery in elderly patients. BMC Geriatr. 2022 Aug 19;22(1):685. doi: 10.1186/s12877-022-03367-y.
- Individual participant dataSharing planned: Undecided
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.
Gaojun Teng, PhD study chair
Zhongda 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 To Investigate the Mortality of the Frailty Patients, run by Zhongda 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyun Sun, Master (18752009886, 977988901@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one-year mortality (time frame: 2019.02-2020.02). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03792373, which also lists 2 linked publications.
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 3 Jan 2019.