- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05814172
ADL and CONUT for Predicting 1-year Mortality Risk in Older Adults After Hip Fracture
October 30, 2023 updated by: Beijing Tongren Hospital
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.
Study Overview
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 Type
Observational
Enrollment (Estimated)
303
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: YING CHEN
- Phone Number: 008613621247560
- Email: trchenying@mail.ccmu.edu.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Beijing Tongren Hospital, Capital Medical University
-
Contact:
- Ying Chen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Older adults with unilateral hip fractures who received surgical treatment in our hospital from January 2014 to December 2021 were enrolled.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Death by 1 y
patients who dieded within 1-year after discharge due to hip fracture surgery
|
no intervention
|
|
Alive at 1 y
patients who survived 1-year after discharge due to hip fracture surgery
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Calculated from the time of discharge, each patient was followed up 1 year, all-cause death in 1 year after discharge was counted.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: QI LIU, Beijing Tongren Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2023
Primary Completion (Estimated)
November 1, 2023
Study Completion (Estimated)
November 1, 2023
Study Registration Dates
First Submitted
March 19, 2023
First Submitted That Met QC Criteria
April 3, 2023
First Posted (Actual)
April 14, 2023
Study Record Updates
Last Update Posted (Actual)
October 31, 2023
Last Update Submitted That Met QC Criteria
October 30, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- TREC2023-KY026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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