Acute Renal FailureIRA-PMSINCT04923750
Detection of Acute Renal Failure Using Hospital Coding Data
An observational study of Acute Renal Failure and Iatrogenic Effect, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure, Iatrogenic Effect, Uremic Toxin
- How many people
- 498 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients under <18 years old
- Patients on dialysis for chronic renal failure
- Hospitalization for a kidney transplant
- Postpartum AKI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Renal Failure, Iatrogenic Effect, Uremic Toxin
- Keywords
- acute renal failure, iatrogenic, pharmaco epidemiology, medico economy, Uremic toxin, PMSI
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
identification of AKIs by codes in the PMSI database
Measured: two years
identification of drug-induced AKIs by codes in the PMSI database
Measured: two years
Secondary outcomes (6)
Variation of performance of the codes according to the characteristics of the AKI
Measured: two years
Variation of performance of the codes according to KDIGO grade
Measured: two years
Variation of performance of the codes according to hospitalization service
Measured: two years
Identification of the type of drugs involved in drug-induced AKI
Measured: two years
incidence of drug-induced AKI
incidence of drug-induced AKI (community-based and hospital-induced AKI (AKI-AH))
Measured: two years
Identification of AKI Risk factors
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start3 Jun 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923750
- Sponsor's protocol ID
- PI2020_843_0018
- Acronym
- IRA-PMSI
- Status last verified
- Jul 2024
- First submitted
- 7 Jun 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury and Drug-related Acute Kidney Injury : Use of Hospital Coding Data for Their Identification
- ClinicalTrials.gov ID
- NCT04923750
- Acronym / sponsor ID
- IRA-PMSI / PI2020_843_0018
- Conditions
- Acute Renal Failure, Iatrogenic Effect, Uremic Toxin
- Keywords
- acute renal failure, iatrogenic, pharmaco epidemiology, medico economy, Uremic toxin, PMSI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Patients under <18 years old
- Patients on dialysis for chronic renal failure
- Hospitalization for a kidney transplant
- Postpartum AKI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
identification of AKIs by codes in the PMSI database
Time frame: two years
identification of drug-induced AKIs by codes in the PMSI database
Time frame: two years
6 secondary outcomes
Variation of performance of the codes according to the characteristics of the AKI
Time frame: two years
Variation of performance of the codes according to KDIGO grade
Time frame: two years
Variation of performance of the codes according to hospitalization service
Time frame: two years
Identification of the type of drugs involved in drug-induced AKI
Time frame: two years
incidence of drug-induced AKI
Time frame: two years
Identification of AKI Risk factors
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Acute Renal Failure
Not yet recruiting
Precision-Medicine Diagnostic Support in Hospitalized Veterans With Acute Kidney Injury
Acute Kidney Injury (AKI)
RecruitingPhase 2
Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury
Kidney Injury, Acute
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Not yet recruitingObservational study
Effect of Filter Lifespan in CRRT on New Infections in Critically Ill Patients With AKI
Acute Kidney Injury
Enrolling by invitationObservational study
ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)
Acute Kidney Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Renal Failure and Iatrogenic Effect, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identification of AKIs by codes in the PMSI database (time frame: two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.