- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05533606
Risk Factors and Machine Learning Model for Beta-Lactam Drugs Related Acute Kidney Injury
November 15, 2023 updated by: Xiao Li,MD, Qianfoshan Hospital
Analysis of Risk Factors of Beta-Lactam Drugs Related Acute Kidney Injury in Hospitalized Patients and Developments of Machine Learning Model
Acute kidney injury (AKI), also known as acute kidney failure (ARF), is a common and complex kidney disease in clinic and an important factor related to poor prognosis of patients in clinic.
In the present study, a single-center retrospective study was conducted in our center.
The clinical data of hospitalized patients received β-Lactam drugs from January 2018 to December 2020 was retrospectively analyzed.
The multiple logistic regression analysis suggested that complicated with hypertension, anemia, pneumonia, shock, sepsis, heart failure, combined use of proton pump inhibitors (PPI), angiotensin-converting enzyme inhibitor (ACEI), angiotensin Ⅱ receptor antagonist (ARB) were independent risk factors for AKI related to β-Lactam drugs.
In clinical practice, patients with acute kidney injury risk factors should be closely monitored for changes in their blood creatinine and urine output to avoid acute kidney injury.
For patients who have suffered from acute kidney injury, the cause should be removed in time and corresponding symptomatic treatment should be given.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
19000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250014
- Xiao Li,MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The patients were included if received treatment with β-lactam drugs and discharged from the hospital between January 1, 2018 and December 31, 2020
Description
Inclusion Criteria:
- All inpatients who used β-lactam drugs 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
AKI Group
|
During hospitalization,patients used Beta-Lactam drugs.
|
|
Non-AKI Group
|
During hospitalization,patients used Beta-Lactam drugs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The incidence of acute kidney injury in hospitalized patients treated with β-lactam drugs
Time Frame: Through study completion,up to half a year.
|
To analyze the incidence of acute kidney injury in hospitalized patients after using β-lactam drugs and to build a prediction model.
|
Through study completion,up to half a year.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
September 2, 2022
First Submitted That Met QC Criteria
September 8, 2022
First Posted (Actual)
September 9, 2022
Study Record Updates
Last Update Posted (Estimated)
November 16, 2023
Last Update Submitted That Met QC Criteria
November 15, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCYY-LX-20220103
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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