Acute Kidney InjurySIPARIO-1NCT06697730
Study of the Incidence and Prognosis of Intrahospital Acute Kidney Injury
An observational study of Acute Kidney Injury, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The goal of this observational study is to investigate the epidemiology of acute kidney injury in hospitalized patients. The main question it aims to answer is: how frequent is the development of acute kidney injury in patients who are hospitalized? Data from participants will be retrospectively collected from medical… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 43,000 participants
- Where
- 1 siteItaly
- Study dates
- 25 Nov 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of all patients admitted to the reference hospital during the indicated time frame; in particular, all patients for whom sufficient data are available to establish the presence or absence of a diagnosis of AKI will be considered.
Who may be able to join
- Patients hospitalised from 01/01/2019 to 31/12/2023
- Availability of a Hospital Discharge Form
- At least one serum creatinine (sCr) determination available
Who cannot join
- Day-hospital admission
- Discharge after an emergency room admission without hospital admission
- Stage IV and V CKD
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
About this study
The goal of this observational study is to investigate the epidemiology of acute kidney injury in hospitalized patients. The main question it aims to answer is: how frequent is the development of acute kidney injury in patients who are hospitalized? Data from participants will be retrospectively collected from medical charts.
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, hospitalized
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized Patients | All patients hospitalized from 01/01/2019 to 12/31/2023. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intra-hospital Acute Kidney Injury
Measured: From 01/01/2019 to 12/31/2023
Secondary outcomes (5)
Incidence of Acute Kidney Injury in different hospital wards
Measured: From 01/01/2019 to 12/31/2023
Association between Acute Kidney Injury development and major discharge diagnoses
Measured: From 01/01/2019 to 12/31/2023
Rate of re-hospitalisation in Acute Kidney Injury (AKI) and non-AKI patients
Measured: From 01/01/2019 to 12/31/2023
Intra-hospital mortality rate in patients who developed AKI compared to those who did not
Measured: From 01/01/2019 to 12/31/2023
Incidence of AKI associated with thrombotic microangiopathy
Comparison between hospital discharge forms and presumptive diagnosis formulated by parametric algorithms based on haematochemical tests performed during hospitalisation
Measured: From 01/01/2019 to 12/31/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start25 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 43,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697730
- Sponsor's protocol ID
- 5261_1
- Acronym
- SIPARIO-1
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Incidence and Prognosis of Intrahospital Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT06697730
- Acronym / sponsor ID
- SIPARIO-1 / 5261_1
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, hospitalized
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 43,000 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Nov 2024 (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.
The goal of this observational study is to investigate the epidemiology of acute kidney injury in hospitalized patients. The main question it aims to answer is: how frequent is the development of acute kidney injury in patients who are hospitalized? Data from participants will be retrospectively collected from medical charts.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized Patients | – | –All patients hospitalized from 01/01/2019 to 12/31/2023. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of all patients admitted to the reference hospital during the indicated time frame; in particular, all patients for whom sufficient data are available to establish the presence or absence of a diagnosis of AKI will be considered.
Key inclusion criteria (3 listed)
- Patients hospitalised from 01/01/2019 to 31/12/2023
- Availability of a Hospital Discharge Form
- At least one serum creatinine (sCr) determination available
Key exclusion criteria (3 listed)
- Day-hospital admission
- Discharge after an emergency room admission without hospital admission
- Stage IV and V CKD
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
Incidence of intra-hospital Acute Kidney Injury
Time frame: From 01/01/2019 to 12/31/2023
5 secondary outcomes
Incidence of Acute Kidney Injury in different hospital wards
Time frame: From 01/01/2019 to 12/31/2023
Association between Acute Kidney Injury development and major discharge diagnoses
Time frame: From 01/01/2019 to 12/31/2023
Rate of re-hospitalisation in Acute Kidney Injury (AKI) and non-AKI patients
Time frame: From 01/01/2019 to 12/31/2023
Intra-hospital mortality rate in patients who developed AKI compared to those who did not
Time frame: From 01/01/2019 to 12/31/2023
Incidence of AKI associated with thrombotic microangiopathy
Time frame: From 01/01/2019 to 12/31/2023
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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 Kidney Injury, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of intra-hospital Acute Kidney Injury (time frame: From 01/01/2019 to 12/31/2023). 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 27 Mar 2026.