Diuretic ToxicityNCT05527054
Risk Factors and Machine Learning Model for Diuretics Related Acute Kidney Injury
An observational study of Diuretic Toxicity and Acute Kidney Injury, run by Qianfoshan Hospital at 1 site in China.
Trial summary
Acute kidney injury (AKI) is a series of clinical syndromes in which serum creatinine (Scr) concentrations increase over a short period of time, or urine output decreases. It has become an increasing global concern.Drug-induced acute kidney injury (D-AKI) refers to kidney injury caused by drugs or their metabolites… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diuretic Toxicity, Acute Kidney Injury
- What is being tested?
- Diuretics
- How many people
- 18,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Jun 2024
- 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
- Adult, Older adult
Study population: The patients were included if received treatment with diuretics and discharged from the hospital between January 1, 2018 and December 31, 2020.
Who may be able to join
- All inpatients who used diuretics during hospitalization Hospital stay ≥ 48h Age ≥ 18 years There were two or more blood creatinine tests during hospitalization
Who cannot join
- Hospital stay < 48h Age < 18 years GFR < 30ml/min/1.73m2 within 48 hours after admission AKI was diagnosed on admission Less than two Scr test results during hospitalization The Scr values were always lower than 40 μmol/L during hospitalization Cases with incomplete medical history information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Risk Factors of Diuretics Related Acute Kidney Injury in Hospitalized Patients and Development of Machine Learning Model
Acute kidney injury (AKI) is a series of clinical syndromes in which serum creatinine (Scr) concentrations increase over a short period of time, or urine output decreases. It has become an increasing global concern.Drug-induced acute kidney injury (D-AKI) refers to kidney injury caused by drugs or their metabolites within 7 days after the use of one or more drugs. The kidneys are rich in blood flow and have the function of acidifying the urine, making them an easy target for drug toxicity. Besides, there are enzymes in the kidney that metabolize some drugs, and if these drugs are metabolized abnormally in the kidney, substances toxic to the kidney may be produced.It was found that about 20% of AKI in hospitalized patients was caused by medications.Diuretics are one of the well-known nephrotoxic drugs, since they can directly or indirectly cause a significant decrease in renal blood perfusion and glomerular filtration rate through the mechanism of affecting tubulobulb feedback, which leads to kidney ischemia and hypoxia.However, there are few real-world studies on the incidence of AKI in hospitalized patients received diuretics. In this study, we aimed to explore the incidence and risk factors analysis of AKI in hospitalized patients received diuretics and develop the machine learning model for diuretics related AKI based on electronic medical record data. With the individual characteristics of patients, the risk of AKI can be evaluated before receiving diuretics, which may provide useful information for clinical decision making to better prevent D-AKI.
- Conditions
- Diuretic Toxicity, Acute Kidney Injury
- Being tested
- Diuretics
- Keywords
- Diuretics, Aute kidney injury, Pharmacoepidemiology, Miss diagnosis, Risk factors, Logic regression
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiureticsOther
Inpatients using diuretics
| Study group | Role | What they receive |
|---|---|---|
| AKI Group | Not described Receives: Other: Diuretics | |
| Non-AKI Group | Not described Receives: Other: Diuretics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
During the patient's hospitalization, acute kidney injury occurred after diuretic use.
Measured: Through study completion，up to half a year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diuretic ToxicityStudies of the same condition, open and under way.
- More trials run by Qianfoshan 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 18,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Li，MD, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527054
- Sponsor's protocol ID
- LCYY-LX-20220101
- Status last verified
- Nov 2023
- First submitted
- 29 Aug 2022
- Last updated
- 3 Apr 2024
- 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 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Risk Factors of Diuretics Related Acute Kidney Injury in Hospitalized Patients and Development of Machine Learning Model
- ClinicalTrials.gov ID
- NCT05527054
- Acronym / sponsor ID
- LCYY-LX-20220101
- Conditions
- Diuretic Toxicity, Acute Kidney Injury
- Keywords
- Diuretics, Aute kidney injury, Pharmacoepidemiology, Miss diagnosis, Risk factors, Logic regression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 2 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.
Acute kidney injury (AKI) is a series of clinical syndromes in which serum creatinine (Scr) concentrations increase over a short period of time, or urine output decreases. It has become an increasing global concern.Drug-induced acute kidney injury (D-AKI) refers to kidney injury caused by drugs or their metabolites within 7 days after the use of one or more drugs. The kidneys are rich in blood flow and have the function of acidifying the urine, making them an easy target for drug toxicity. Besides, there are enzymes in the kidney that metabolize some drugs, and if these drugs are metabolized abnormally in the kidney, substances toxic to the kidney may be produced.It was found that about 20% of AKI in hospitalized patients was caused by medications.Diuretics are one of the well-known nephrotoxic drugs, since they can directly or indirectly cause a significant decrease in renal blood perfusion and glomerular filtration rate through the mechanism of affecting tubulobulb feedback, which leads to kidney ischemia and hypoxia.However, there are few real-world studies on the incidence of AKI in hospitalized patients received diuretics. In this study, we aimed to explore the incidence and risk factors analysis of AKI in hospitalized patients received diuretics and develop the machine learning model for diuretics related AKI based on electronic medical record data. With the individual characteristics of patients, the risk of AKI can be evaluated before receiving diuretics, which may provide useful information for clinical decision making to better prevent D-AKI.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI Group | – | Other: Diuretics |
| Non-AKI Group | – | Other: Diuretics |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients were included if received treatment with diuretics and discharged from the hospital between January 1, 2018 and December 31, 2020.
Key inclusion criteria (1 listed)
- All inpatients who used diuretics during hospitalization Hospital stay ≥ 48h Age ≥ 18 years There were two or more blood creatinine tests during hospitalization
Key exclusion criteria (1 listed)
- Hospital stay < 48h Age < 18 years GFR < 30ml/min/1.73m2 within 48 hours after admission AKI was diagnosed on admission Less than two Scr test results during hospitalization The Scr values were always lower than 40 μmol/L during hospitalization Cases with incomplete medical history information
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 |
|---|---|---|
| DiureticsInpatients using diuretics | Other | AKI Group, Non-AKI Group |
Primary outcome
Acute kidney injury
Time frame: Through study completion，up to half a year.
During the patient's hospitalization, acute kidney injury occurred after diuretic use.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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.
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 Diuretic Toxicity and Acute Kidney Injury, run by Qianfoshan 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 Apr 2024. 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?
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?
Acute kidney injury (time frame: Through study completion，up to half a year.). 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 3 Apr 2024.