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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05527054
Other study ID # LCYY-LX-20220101
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date June 30, 2024

Study information

Verified date November 2023
Source Qianfoshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 18000
Est. completion date June 30, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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: 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

Study Design


Intervention

Other:
Diuretics
Inpatients using diuretics

Locations

Country Name City State
China Xiao Li,MD Jinan ???

Sponsors (1)

Lead Sponsor Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acute kidney injury During the patient's hospitalization, acute kidney injury occurred after diuretic use. Through study completion,up to half a year.
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