NCT05527054

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 3, 2024

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

August 29, 2022

Last Update Submit

April 2, 2024

Conditions

Keywords

DiureticsAute kidney injuryPharmacoepidemiologyMiss diagnosisRisk factorsLogic regression

Outcome Measures

Primary Outcomes (1)

  • Acute kidney injury

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

    Through study completion,up to half a year.

Study Arms (2)

AKI Group

Other: Diuretics

Non-AKI Group

Other: Diuretics

Interventions

Inpatients using diuretics

AKI GroupNon-AKI Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiao Li,MD

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Diuretics

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Natriuretic AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 29, 2022

First Posted

September 2, 2022

Study Start

July 1, 2022

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

April 3, 2024

Record last verified: 2023-11

Locations