Maintenance HemodialysisNCT05699447
A New Risk Score for Predicting 1-year Mortality in Older r Maintenance Hemodialysis Patients.
An observational study of Maintenance Hemodialysis and Older Patient, run by Beijing Friendship Hospital.
Trial summary
The goal of this retrospective observational cohort study is to analysis the 1-year mortality in older patients undergoing maintenance hemodialysis. The main question it aims to answer is to explore the risk factors affecting the mortality of older patients undergoing maintenance hemodialysis and establish a risk… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Maintenance Hemodialysis, Older Patient
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2022to 16 Jan 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Data of older patients (age ≥65 years old) undergoing maintenance hemodialysis were collected from 2012-1-December 31, 2014, with data from Beijing Blood Purification Quality Control and Improvement Center (BJHDQCIC).
Who may be able to join
- Age ≥65 years.
- More than 6-month history of hemodialysis,the frequency is 3 times a week, and the dialysis time is 4 hours each.
- The dialysate Ca concentration was 1.5 mmol/L and the bicarbonate level was 32 -- 35 mmol/L.
Who cannot join
- Lack of demographic information, clinical history, or relevant laboratory values (including pre-dialysis serum calcium, phosphorus, iPTH, haemoglobin, albumin, creatinine, total cholesterol, and Kt/v for urea).
About this study
Official title: A New Risk Score for Predicting 1-year Mortality in Older r Maintenance Hemodialysis Patients.A Cohort Study in Beijing.
The goal of this retrospective observational cohort study is to analysis the 1-year mortality in older patients undergoing maintenance hemodialysis. The main question it aims to answer is to explore the risk factors affecting the mortality of older patients undergoing maintenance hemodialysis and establish a risk prediction score.
Data of older patients (age ≥65 years old) undergoing maintenance hemodialysis were collected from 2012-1-December 31, 2014, with data from Beijing Blood Purification Quality Control and Improvement Center (BJHDQCIC). Logistic regression model was used to evaluate the 1-year mortality and the influence of predictive factors. Internal validation of the model was performed using the bootstrap 1000 repeat sampling method. Area under receiver operating characteristic curve (AUC) was used to evaluate the predictive ability of the model.
- Conditions
- Maintenance Hemodialysis, Older Patient
- Keywords
- Older patients, maintenance hemodialysis, mortality, risk prediction score.
What is being measured
The primary outcome is the main question the study is designed to answer.
the 1-year mortality in older patients undergoing maintenance hemodialysis
Measured: Data of older patients (age ≥65 years old) undergoing maintenance hemodialysis were collected from 2012-1-December 31, 2014, with data from Beijing Blood Purification Quality Control and Improvement Center (BJHDQCIC).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start28 Nov 2022
- Primary completion10 Jan 2023
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maintenance HemodialysisStudies 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
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenhu Liu, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699447
- Sponsor's protocol ID
- 2022-P2-385-01
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Risk Score for Predicting 1-year Mortality in Older r Maintenance Hemodialysis Patients.A Cohort Study in Beijing.
- ClinicalTrials.gov ID
- NCT05699447
- Acronym / sponsor ID
- 2022-P2-385-01
- Conditions
- Maintenance Hemodialysis, Older Patient
- Keywords
- Older patients, maintenance hemodialysis, mortality, risk prediction score.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 26 Jan 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.
The goal of this retrospective observational cohort study is to analysis the 1-year mortality in older patients undergoing maintenance hemodialysis. The main question it aims to answer is to explore the risk factors affecting the mortality of older patients undergoing maintenance hemodialysis and establish a risk prediction score.
Data of older patients (age ≥65 years old) undergoing maintenance hemodialysis were collected from 2012-1-December 31, 2014, with data from Beijing Blood Purification Quality Control and Improvement Center (BJHDQCIC). Logistic regression model was used to evaluate the 1-year mortality and the influence of predictive factors. Internal validation of the model was performed using the bootstrap 1000 repeat sampling method. Area under receiver operating characteristic curve (AUC) was used to evaluate the predictive ability of the model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Data of older patients (age ≥65 years old) undergoing maintenance hemodialysis were collected from 2012-1-December 31, 2014, with data from Beijing Blood Purification Quality Control and Improvement Center (BJHDQCIC).
Key inclusion criteria (3 listed)
- Age ≥65 years.
- More than 6-month history of hemodialysis,the frequency is 3 times a week, and the dialysis time is 4 hours each.
- The dialysate Ca concentration was 1.5 mmol/L and the bicarbonate level was 32 -- 35 mmol/L.
Key exclusion criteria (1 listed)
- Lack of demographic information, clinical history, or relevant laboratory values (including pre-dialysis serum calcium, phosphorus, iPTH, haemoglobin, albumin, creatinine, total cholesterol, and Kt/v for urea).
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
the 1-year mortality in older patients undergoing maintenance hemodialysis
Time frame: Data of older patients (age ≥65 years old) undergoing maintenance hemodialysis were collected from 2012-1-December 31, 2014, with data from Beijing Blood Purification Quality Control and Improvement Center (BJHDQCIC).
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 26 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Maintenance Hemodialysis and Older Patient, run by Beijing Friendship Hospital.
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 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: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
the 1-year mortality in older patients undergoing maintenance hemodialysis (time frame: Data of older patients (age ≥65 years old) undergoing maintenance hemodialysis were collected from 2012-1-December 31, 2014, with data from Beijing Blood Purification Quality Control and Improvement Center (BJHDQCIC).). 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 26 Jan 2023.