NCT04923750

Brief Summary

AKI is a rapid and usually reversible impairment of kidney function that is life-threatening in the short term well described by the "Kidney Disease: Improving Global Outcomes - KDIGO" classification of 2012. Whatever etiology of acute renal failure, drug iatrogeny still has its place. Hospital data from the information systems medicalization program (PMSI) can be used for epidemiological research. No study has yet been performed on these data to assess drug-related AKI. However, it should be remembered that these databases were not originally designed for research purposes but for reimbursement of care. Therefore, before conducting a large-scale study, it remains important to determine the validity and representativeness of the codes used for coding the studied events. The objective of this project is therefore to validate the use of hospital coding to identify AKI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
498

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

2.6 years

First QC Date

June 7, 2021

Last Update Submit

July 2, 2024

Conditions

Keywords

acute renal failureiatrogenicpharmaco epidemiologymedico economyUremic toxinPMSI

Outcome Measures

Primary Outcomes (2)

  • identification of AKIs by codes in the PMSI database

    two years

  • identification of drug-induced AKIs by codes in the PMSI database

    two years

Secondary Outcomes (6)

  • Variation of performance of the codes according to the characteristics of the AKI

    two years

  • Variation of performance of the codes according to KDIGO grade

    two years

  • Variation of performance of the codes according to hospitalization service

    two years

  • Identification of the type of drugs involved in drug-induced AKI

    two years

  • incidence of drug-induced AKI

    two years

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized at the CHU Amiens Picardie during 6 months and for which at least two plasma creatinine measurements were taken during the hospitalization

You may qualify if:

  • Patients over \> = 18 years old
  • Patients hospitalized at the CHU Amiens Picardie during 6 months
  • patients for which at least two plasma creatinine measurements were taken during the hospitalization

You may not qualify if:

  • Patients under \<18 years old
  • Patients on dialysis for chronic renal failure
  • Hospitalization for a kidney transplant
  • Postpartum AKI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 11, 2021

Study Start

June 3, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations