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Status unknownNCT05527054Updated Apr 3, 2024

Risk Factors and Machine Learning Model for Diuretics Related Acute Kidney Injury

An observational study in Diuretic Toxicity and Acute Kidney Injury, sponsored by Qianfoshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-04-03.

Sponsored by Qianfoshan Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
18,000
Ages
18 Years to 100 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Diuretic Toxicity
  • Acute Kidney Injury

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Keywords

  • Diuretics
  • Aute kidney injury
  • Pharmacoepidemiology
  • Miss diagnosis
  • Risk factors
  • Logic regression
03

In context

Acute Kidney Injury

1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.

This study's planned enrollment of 18,000 is above the median of 156 across 795 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Qianfoshan Hospital is the lead sponsor of 143 studies on the registry; 74 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The patients were included if received treatment with diuretics and discharged from the hospital between January 1, 2018 and December 31, 2020.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

All inpatients who used diuretics during hospitalization Hospital stay ≥ 48h Age ≥ 18 years There were two or more blood creatinine tests during hospitalization

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
18,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • AKI Group

    Other: Diuretics

  • Non-AKI Group

    Other: Diuretics

Interventions

  • OtherDiuretics

    Inpatients using diuretics

06

What researchers measure

Primary outcomes

  1. Acute kidney injury

    During the patient's hospitalization, acute kidney injury occurred after diuretic use.

    Time frame: Through study completion,up to half a year.

07

Study locations

1 site
  • Xiao Li,MD
    Jinan, Shandong 250014, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2022 to primary completion in Dec 2023, 17 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2022
First posted
Sep 2, 2022
StartActual
Jul 1, 2022
Primary completionActual
Dec 31, 2023
CompletionEst.
Jun 30, 2024
Last update
Apr 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05527054
Responsible party
Xiao Li,MD (MD, Qianfoshan Hospital) — Principal investigator
First posted
Sep 2, 2022
Start date
Jul 1, 2022
Primary completion
Dec 31, 2023
Completion
Jun 30, 2024 (estimated)
Last update
Apr 3, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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