- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04923750
Detection of Acute Renal Failure Using Hospital Coding Data (IRA-PMSI)
July 2, 2024 updated by: Centre Hospitalier Universitaire, Amiens
Acute Kidney Injury and Drug-related Acute Kidney Injury : Use of Hospital Coding Data for Their Identification
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Acute kidney injury (AKI) is a rapid and usually reversible impairment of kidney function that is life-threatening in the short term; the grades of which are defined by the KDIGO classification of 2012.
Whatever etiology of acute renal failure, drug iatrogeny still has its place.
Data literature indicate that AKI affects more than one in five adults worldwide while hospitalized, with an associated mortality rate above 20%.
It constitutes a non-negligible part of hospitalizations when it is acquired in the community, and also causes prolongations of hospitalizations, and therefore an increase in the cost for the hospital.
Hospital data from the information systems medicalization program (PMSI) is a device that is part of the reform of the French health system with the aim of reducing inequalities in resources between health establishments.
Since 2007, it has been possible to link all discharge summaries for one patient.
The diagnoses identified during hospitalization are coded according to the 10th edition of the International Classification of Diseases (ICD-10).
The data from PMSI coding can be used for epidemiological research.
The majority of studies were related to patients with chronic kidney disease, especially dialysis patients.
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 events to be studied.
Study Type
Observational
Enrollment (Actual)
498
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
-
-
-
Amiens, France, 80480
- CHU Amiens
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-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients under <18 years old
- Patients on dialysis for chronic renal failure
- Hospitalization for a kidney transplant
- Postpartum AKI
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: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
identification of AKIs by codes in the PMSI database
Time Frame: two years
|
two years
|
|
identification of drug-induced AKIs by codes in the PMSI database
Time Frame: two years
|
two years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Variation of performance of the codes according to the characteristics of the AKI
Time Frame: two years
|
two years
|
|
|
Variation of performance of the codes according to KDIGO grade
Time Frame: two years
|
two years
|
|
|
Variation of performance of the codes according to hospitalization service
Time Frame: two years
|
two years
|
|
|
Identification of the type of drugs involved in drug-induced AKI
Time Frame: two years
|
two years
|
|
|
incidence of drug-induced AKI
Time Frame: two years
|
incidence of drug-induced AKI (community-based and hospital-induced AKI (AKI-AH))
|
two years
|
|
Identification of AKI Risk factors
Time Frame: two years
|
two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
June 3, 2021
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
June 7, 2021
First Submitted That Met QC Criteria
June 7, 2021
First Posted (Actual)
June 11, 2021
Study Record Updates
Last Update Posted (Actual)
July 3, 2024
Last Update Submitted That Met QC Criteria
July 2, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2020_843_0018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.