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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04923750
Other study ID # PI2020_843_0018
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 3, 2021
Est. completion date December 2023

Study information

Verified date February 2023
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 498
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary identification of AKIs by codes in the PMSI database two years
Primary identification of drug-induced AKIs by codes in the PMSI database two years
Secondary Variation of performance of the codes according to the characteristics of the AKI two years
Secondary Variation of performance of the codes according to KDIGO grade two years
Secondary Variation of performance of the codes according to hospitalization service two years
Secondary Identification of the type of drugs involved in drug-induced AKI two years
Secondary incidence of drug-induced AKI incidence of drug-induced AKI (community-based and hospital-induced AKI (AKI-AH)) two years
Secondary Identification of AKI Risk factors two years
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