All-cause MortalityNCT05814172
ADL and CONUT for Predicting 1-year Mortality Risk in Older Adults After Hip Fracture
An observational study of All-cause Mortality, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Hip fracture has a serious impact on the quality of life and even the survival of older adults. The multidisciplinary management of hip fracture has been shown to be effective in improving patient outcome and cost-effective in international studies. Read more about this study
- Who is it for?
- Ages 65 to 110 years
- Conditions the study is for
- All-cause Mortality
- How many people
- 303 participants
- Where
- 1 siteChina
- Study dates
- Oct 2023to Nov 2023
- 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 110 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Older adults with unilateral hip fractures who received surgical treatment in our hospital from January 2014 to December 2021 were enrolled.
Who may be able to join
- patients aged ≧65 years old;
- patients diagnosed with hip fracture, including femoral neck fracture, femoral intertrochanteric fracture, and femoral subtrochanteric fracture;
- patients whose injury was within 21 days of presentation.
Who cannot join
- patients aged <65 years old;
- patients with pathological fractures due to tumor metastasis or infection or inherited bone disorder;
- patients with avascular necrosis of femoral head;
- patients with periprosthetic fractures;
- old fracture patients treated more than 21 days from injury;
- patients with severe trauma or fracture in other parts;
- patients and their families who could not bear the surgical risk and are unwilling to receive surgical treatment;
- patients died in hospital.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730
YING CHEN
About this study
Official title: Beijing Tongren Hospital, Capital Medical University
Hip fracture has a serious impact on the quality of life and even the survival of older adults. The multidisciplinary management of hip fracture has been shown to be effective in improving patient outcome and cost-effective in international studies. As geriatricians and members of a multi-disciplinary team（MDT）, we are aware of various scores in predicting the 1-year mortality risk in hospitalized older adults with multimorbidity. However, given the need for a deeper understanding of the preoperative status of elderly patients who were suffering from pain, tension, anxiety, delirium,etc., we hope to explore a simple, quick, objective, and accurate method for assessing the status of elderly patients with hip fractures to predict their survival risk.
Read the detailed description
This was a single-center retrospective cohort study which were approved by the Clinical Research Ethics Committee of Beijing Tongren Hospital, Capital Medical University (TREC2023-KY026). Demographic characteristics and medical parameters, such as age, gender, body mass index (BMI), comorbidities, hemoglobin , lymphocytes, C-reactive protein (CRP), fasting blood glucose, creatinine, total protein, albumin, triglycerides, total cholesterol and American Association of Anesthesiologists (ASA) were collected from the electronic medical record system. Controlling nutritional status (CONUT) was calculated from 3 variables: serum albumin concentration, total cholesterol concentration, and lymphocyte count, as previously reported. All enrolled patients were followed-up in an outpatients setting. Survival data were obtained via direct contact with patients or patients' caregiver by their physicians at the hospital , or via telephone interview of their family by dedicated coordinators and investigators. The follow-up lasted for one year and the last follow-up was ended on December 31, 2022. All analyses were performed using SPSS version 19.0 (SPSS, Chicago, IL, USA).
- Conditions
- All-cause Mortality
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Death by 1 y | patients who dieded within 1-year after discharge due to hip fracture surgery Receives: Other: no intervention | |
| Alive at 1 y | patients who survived 1-year after discharge due to hip fracture surgery Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
After discharge, all enrolled patients were followed-up in an outpatients setting. Survival data were obtained via direct contact with patients or patients' caregiver by their physicians at the hospital , or via telephone interview of their family by dedicated coordinators and investigators. Survival data were obtained via direct contact with patients or patients' caregiver by their physicians at the hospital , or via telephone interview of their family by dedicated coordinators and investigators. Outcomes were recorded.
Measured: Calculated from the time of discharge, each patient was followed up 1 year, all-cause death in 1 year after discharge was counted.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study startOct 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All-cause MortalityStudies of the same condition, open and under way.
- More trials run by Beijing Tongren 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
- Retrospective
- Enrolment
- 303 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- QI LIU, Study director, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814172
- Sponsor's protocol ID
- TREC2023-KY026
- Status last verified
- Mar 2023
- First submitted
- 19 Mar 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beijing Tongren Hospital, Capital Medical University
- ClinicalTrials.gov ID
- NCT05814172
- Acronym / sponsor ID
- TREC2023-KY026
- Conditions
- All-cause Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 303 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 14 Apr 2023 (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.
Hip fracture has a serious impact on the quality of life and even the survival of older adults. The multidisciplinary management of hip fracture has been shown to be effective in improving patient outcome and cost-effective in international studies. As geriatricians and members of a multi-disciplinary team（MDT）, we are aware of various scores in predicting the 1-year mortality risk in hospitalized older adults with multimorbidity. However, given the need for a deeper understanding of the preoperative status of elderly patients who were suffering from pain, tension, anxiety, delirium,etc., we hope to explore a simple, quick, objective, and accurate method for assessing the status of elderly patients with hip fractures to predict their survival risk.
Detailed description
This was a single-center retrospective cohort study which were approved by the Clinical Research Ethics Committee of Beijing Tongren Hospital, Capital Medical University (TREC2023-KY026). Demographic characteristics and medical parameters, such as age, gender, body mass index (BMI), comorbidities, hemoglobin , lymphocytes, C-reactive protein (CRP), fasting blood glucose, creatinine, total protein, albumin, triglycerides, total cholesterol and American Association of Anesthesiologists (ASA) were collected from the electronic medical record system. Controlling nutritional status (CONUT) was calculated from 3 variables: serum albumin concentration, total cholesterol concentration, and lymphocyte count, as previously reported. All enrolled patients were followed-up in an outpatients setting. Survival data were obtained via direct contact with patients or patients' caregiver by their physicians at the hospital , or via telephone interview of their family by dedicated coordinators and investigators. The follow-up lasted for one year and the last follow-up was ended on December 31, 2022. All analyses were performed using SPSS version 19.0 (SPSS, Chicago, IL, USA).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Death by 1 y | – | Other: no interventionpatients who dieded within 1-year after discharge due to hip fracture surgery |
| Alive at 1 y | – | Other: no interventionpatients who survived 1-year after discharge due to hip fracture surgery |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older adults with unilateral hip fractures who received surgical treatment in our hospital from January 2014 to December 2021 were enrolled.
Key inclusion criteria (3 listed)
- patients aged ≧65 years old;
- patients diagnosed with hip fracture, including femoral neck fracture, femoral intertrochanteric fracture, and femoral subtrochanteric fracture;
- patients whose injury was within 21 days of presentation.
Key exclusion criteria (8 listed)
- patients aged <65 years old;
- patients with pathological fractures due to tumor metastasis or infection or inherited bone disorder;
- patients with avascular necrosis of femoral head;
- patients with periprosthetic fractures;
- old fracture patients treated more than 21 days from injury;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | Alive at 1 y, Death by 1 y |
Primary outcome
Mortality
Time frame: Calculated from the time of discharge, each patient was followed up 1 year, all-cause death in 1 year after discharge was counted.
After discharge, all enrolled patients were followed-up in an outpatients setting. Survival data were obtained via direct contact with patients or patients' caregiver by their physicians at the hospital , or via telephone interview of their family by dedicated coordinators and investigators. Survival data were obtained via direct contact with patients or patients' caregiver by their physicians at the hospital , or via telephone interview of their family by dedicated coordinators and investigators. Outcomes were recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
QI LIU study director
Beijing Tongren 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 All-cause Mortality, run by Beijing Tongren 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 3 inclusion and 8 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 31 Oct 2023. 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 YING CHEN (008613621247560, trchenying@mail.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Calculated from the time of discharge, each patient was followed up 1 year, all-cause death in 1 year after discharge was counted.). 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 31 Oct 2023; AzTrials last refreshed its copy on 4 Nov 2026.