Chronic Kidney DiseasesNCT05550467
24-hour Urinary Electrolyte Excretion in Chronic Kidney Disease
An observational study of Chronic Kidney Diseases and Electrolyte Imbalance, run by Chinese PLA General Hospital.
Trial summary
Association between excretion pattern and development trajectory of urinary electrolytes (urine sodium, urine potassium, urine chlorine, urine magnesium, urine calcium, urine phosphorus, urine creatinine, urea, uric acid, urine glucose, urine protein, urine retinol) and adverse prognosis in patients with chronic… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Kidney Diseases, Electrolyte Imbalance
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Jul 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age ≥ 18 years, chronic kidney disease patients without kidney replacement therapy who had 24-h urine eletrocyte tests.
Who may be able to join
- Our study is a retrospective cohort study. The study included patients with adult（Age≥18years）CKD who were hospitalized in the Department of Nephrology, First Medical Center of Chinese PLA General Hospital from January 2014 to July 2022. Patients with CKD who had one or more 24-hour urinary electrolyte excretion tests at intervals of more than three months were included in the subgroup analysis.
Who cannot join
- Patients with hemodialysis therapy and urine volume less than 500ml were excluded.
About this study
Official title: 24-hour Urinary Electrolyte Excretion and Renal Prognosis in Chronic Kidney Disease：a Retrospective Cohort Study
Association between excretion pattern and development trajectory of urinary electrolytes (urine sodium, urine potassium, urine chlorine, urine magnesium, urine calcium, urine phosphorus, urine creatinine, urea, uric acid, urine glucose, urine protein, urine retinol) and adverse prognosis in patients with chronic kidney disease
- Conditions
- Chronic Kidney Diseases, Electrolyte Imbalance
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney disease progression
eGFR decline > 50%; dialysis; kidney transplant
Measured: 2014.1.1-2022.7.31
Death
All cause death
Measured: 2014.1.1-2022.7.31
Secondary outcomes (1)
Cardiovascular disease
myocardial infarction, angina pectoris, stable heart failure, peripheral artery disease , revascularization, cerebrovascular events
Measured: 2014.1.1-2022.7.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Jan 2014
- Primary completion30 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIANG Shuang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550467
- Sponsor's protocol ID
- 2015BAI12B06-03
- Status last verified
- Sep 2022
- First submitted
- 19 Sep 2022
- Last updated
- 22 Sep 2022
- 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 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24-hour Urinary Electrolyte Excretion and Renal Prognosis in Chronic Kidney Disease：a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05550467
- Acronym / sponsor ID
- 2015BAI12B06-03
- Conditions
- Chronic Kidney Diseases, Electrolyte Imbalance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 22 Sep 2022 (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.
Association between excretion pattern and development trajectory of urinary electrolytes (urine sodium, urine potassium, urine chlorine, urine magnesium, urine calcium, urine phosphorus, urine creatinine, urea, uric acid, urine glucose, urine protein, urine retinol) and adverse prognosis in patients with chronic kidney disease
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age ≥ 18 years, chronic kidney disease patients without kidney replacement therapy who had 24-h urine eletrocyte tests.
Key inclusion criteria (1 listed)
- Our study is a retrospective cohort study. The study included patients with adult（Age≥18years）CKD who were hospitalized in the Department of Nephrology, First Medical Center of Chinese PLA General Hospital from January 2014 to July 2022. Patients with CKD who had one or more 24-hour urinary electrolyte excretion tests at intervals of more than three months were included in the subgroup analysis.
Key exclusion criteria (1 listed)
- Patients with hemodialysis therapy and urine volume less than 500ml were excluded.
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
Kidney disease progression
Time frame: 2014.1.1-2022.7.31
eGFR decline > 50%; dialysis; kidney transplant
Death
Time frame: 2014.1.1-2022.7.31
All cause death
1 secondary outcome
Cardiovascular disease
Time frame: 2014.1.1-2022.7.31
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 22 Sep 2022.
- 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.
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 Chronic Kidney Diseases and Electrolyte Imbalance, run by Chinese PLA General 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 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: finished, as of the sponsor's last update on 22 Sep 2022. 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?
Kidney disease progression (time frame: 2014.1.1-2022.7.31). 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 22 Sep 2022.