NCT05533606

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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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

September 2, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

12 months

First QC Date

September 2, 2022

Last Update Submit

November 15, 2023

Conditions

Keywords

Beta-Lactam drugsAcute kidney injuryPharmacoepidemiologyMiss diagnosisRisk factorsLogic regression

Outcome Measures

Primary Outcomes (1)

  • The incidence of acute kidney injury in hospitalized patients treated with β-lactam drugs

    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.

Study Arms (2)

AKI Group

Drug: Beta-Lactam Drugs

Non-AKI Group

Drug: Beta-Lactam Drugs

Interventions

During hospitalization,patients used Beta-Lactam drugs.

AKI GroupNon-AKI Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

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 InjuryDisease

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of pharmacy

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 9, 2022

Study Start

July 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations