---
title: Risk Factors and Machine Learning Model for Aminoglycines Related Acute Kidney Injury
nct_id: NCT05533593
overall_status: COMPLETED
sponsor: Qianfoshan Hospital
study_type: OBSERVATIONAL
primary_condition: Aminoglycoside Toxicity
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05533593.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05533593"
ct_last_update_post_date: 2023-11-18
last_seen_at: "2026-05-12T06:38:54.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Risk Factors and Machine Learning Model for Aminoglycines Related Acute Kidney Injury

**Official Title:** Analysis of Risk Factors of Aminoglycines Related Acute Kidney Injury in Hospitalized Patients and Development of Machine Learning Model

**NCT ID:** [NCT05533593](https://clinicaltrials.gov/study/NCT05533593)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 8000
- **Lead Sponsor:** Qianfoshan Hospital
- **Conditions:** Aminoglycoside Toxicity, Acute Kidney Injury
- **Start Date:** 2022-07-01
- **Completion Date:** 2023-10-31
- **CT.gov Last Update:** 2023-11-18

## Brief Summary

Drug-induced acute kidney injury (D-AKI) can occur after treatment with aminoglycosides. Predicting the risk of D-AKI is important for a tailored prevention and palliation strategy. There are currently no studies to construct a model for predicting the risk of D-AKI associated with aminoglycosides. Therefore, the study aimed to develop a model to predict the risk of D-AKI that could be used in clinical practice. Clinical data of inpatients treated with aminoglycosides at the First Affiliated Hospital of Shandong First Medical University from January 2018 to December 2020, were collected. The primary endpoint was D-AKI, defined according to the 2012 Global Outcomes for Kidney Disease Improvement (KDIGO). Patient clinical information, including demographic information, admission and discharge information, disease history, medication information, and laboratory tests, was obtained through an in-hospital electronic medical record system. Independent risk factors associated with D-AKI will be screened by univariate and multifactorial analyses. Covariates with significant differences (P \< 0.05) were included in logistic regression models. The models were evaluated by the area under the curve (AUC) of the receiver operating characteristic curve (ROC) obtained by ten-fold cross-validation. Future studies are needed to test the application of this model in clinical practice to determine whether D-AKI in this setting can be predicted and mitigated.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 100 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

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

Exclusion Criteria:

* Hospital stay \< 48h
* Age \<18 years
* Glomerular filtration rate (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
```

## Arms

- **AKI Group**
- **Non-AKI Group**

## Interventions

- **Aminoglycoside** (DRUG) — Inpatients using aminoglycoside

## Primary Outcomes

- **The incidence of acute kidney injury in hospitalized patients treated with aminoglycosides** _(time frame: Through study completion，up to half a year.)_ — To analyze the incidence of acute kidney injury in hospitalized patients after using aminoglycosides and to build a prediction model.

## Locations (1)

- Xiao Li，MD, Jinan, Shandong, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.xiao li，md|jinan|shandong|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05533593.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05533593*  
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