Acute Kidney InjuryGENAKINCT05151003
Epidemiology of In-hospital Acute Kidney Injury
An observational study of Acute Kidney Injury and Dialysis; Complications, run by Universita degli Studi di Genova at 1 site in Italy.
Trial summary
Retrospective observational study to investigate acute kidney injury (AKI) epidemiology and outcomes in patients hospitalized in University Hospital San Martino, Genova, Italy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Dialysis; Complications, Chronic Kidney Diseases
- What is being tested?
- Data collection
- How many people
- 60,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2021to 1 Dec 2025
- 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: Adult patients admitted to Policlinico Universitario San Martino, Genova, Italy (including those with COVID-19).
Who may be able to join
- Patients admitted to University Hospital San Martino, Italy
- We'll include also patients affected by Coronavirus disease 19 (COVID-19).
Who cannot join
- Hemodialysis patients
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Martino
Genova
Pasquale Esposito, Prof, 00390105557162, pasquale.esposito@unige.it
Pasquale Esposito
About this study
Official title: Analysis of In-hospital Acute Kidney Injury Epidemiology, Treatment and Outcomes
Retrospective observational study to investigate acute kidney injury (AKI) epidemiology and outcomes in patients hospitalized in University Hospital San Martino, Genova, Italy.
Read the detailed description
A retrospective observational study was designed to investigate acute kidney injury (AKI) epidemiology and outcome in patients hospitalized in University Hospital San Martino, Genova, Italy.
All data will be extracted from the hospital electronic database. The investigators will evaluate demographic, clinical and laboratory data, including age, sex, serum creatinine (sCr), sodium and electrolytes, intensive care unit (ICU) admission, length of hospital stay, death, comorbidities and primary diagnosis codes at the hospital discharge (using International Classification of Diseases-ICD-9- codes).
The investigators will include also patients affected by Coronavirus disease 19 (COVID-19).
The primary endpoint will be to describe AKI epidemiology, secondary endpoints will be to evaluate AKI-related risk factors and clinical outcomes, such as length of stay and mortality.
Moreover, the investigators will describe the differences in the outcome and treatments of AKI patients in the medical wards and ICU.
- Being tested
- Data collection
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Collection and analysis of data related to AKI epidemiology, treatment and outcomes
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted to University Hospital San Martino, Genova, Italy | Adult patients admitted to University Hospital San Martino, Genova, Italy Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury incidence
Rate of in-hospital Acute Kidney Injury incidence
Measured: Collection of retrospective data from 2016
Acute Kidney Injury severity
Staging of in-hospital Acute Kidney Injury according to the KDIGO guidelines
Measured: Collection of retrospective data from 2016
Secondary outcomes (2)
Mortality in Acute Kidney Injury patients
Rate of in-hospital mortality among patients with Acute Kidney Injury
Measured: Collection of retrospective data from 2016
Creatinine clearance after discharge
Data on kidney function after the discharge in Acute Kidney Injury patients
Measured: Collection of retrospective data from 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Aug 2021
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Dec 2025 (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.
- 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
- 60,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita degli Studi di Genova
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale Policlinico San Martino
- Responsible party
- Principal investigator, Pasquale Esposito, Universita degli Studi di Genova
- Investigators
- Pasquale Esposito, Prof, Principal investigator, University of Genova, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151003
- Sponsor's protocol ID
- CER Liguria: 515/2020
- Acronym
- GENAKI
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will be anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of In-hospital Acute Kidney Injury Epidemiology, Treatment and Outcomes
- ClinicalTrials.gov ID
- NCT05151003
- Acronym / sponsor ID
- GENAKI / CER Liguria: 515/2020
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- Universita degli Studi di GenovaUniversity, hospital or other
- Collaborators
- Ospedale Policlinico San Martino
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Dec 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.
Retrospective observational study to investigate acute kidney injury (AKI) epidemiology and outcomes in patients hospitalized in University Hospital San Martino, Genova, Italy.
Detailed description
A retrospective observational study was designed to investigate acute kidney injury (AKI) epidemiology and outcome in patients hospitalized in University Hospital San Martino, Genova, Italy.
All data will be extracted from the hospital electronic database. The investigators will evaluate demographic, clinical and laboratory data, including age, sex, serum creatinine (sCr), sodium and electrolytes, intensive care unit (ICU) admission, length of hospital stay, death, comorbidities and primary diagnosis codes at the hospital discharge (using International Classification of Diseases-ICD-9- codes).
The investigators will include also patients affected by Coronavirus disease 19 (COVID-19).
The primary endpoint will be to describe AKI epidemiology, secondary endpoints will be to evaluate AKI-related risk factors and clinical outcomes, such as length of stay and mortality.
Moreover, the investigators will describe the differences in the outcome and treatments of AKI patients in the medical wards and ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to University Hospital San Martino, Genova, Italy | – | Other: Data collectionAdult patients admitted to University Hospital San Martino, Genova, Italy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to Policlinico Universitario San Martino, Genova, Italy (including those with COVID-19).
Key inclusion criteria (2 listed)
- Patients admitted to University Hospital San Martino, Italy
- We'll include also patients affected by Coronavirus disease 19 (COVID-19).
Key exclusion criteria (1 listed)
- Hemodialysis patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionCollection and analysis of data related to AKI epidemiology, treatment and outcomes | Other | Patients admitted to University Hospital San Martino, Genova, Italy |
Primary outcome
Acute Kidney Injury incidence
Time frame: Collection of retrospective data from 2016
Rate of in-hospital Acute Kidney Injury incidence
Acute Kidney Injury severity
Time frame: Collection of retrospective data from 2016
Staging of in-hospital Acute Kidney Injury according to the KDIGO guidelines
2 secondary outcomes
Mortality in Acute Kidney Injury patients
Time frame: Collection of retrospective data from 2016
Creatinine clearance after discharge
Time frame: Collection of retrospective data from 2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No. Patient data will be anonymized.
Related trials for Acute Kidney Injury
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
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Acute Kidney Injury and Ultra-endurance Running
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Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
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Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Pasquale Esposito, Prof principal investigator
University of Genova, Italy
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 and Dialysis; Complications, run by Universita degli Studi di Genova 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pasquale Esposito (00390105555362, pasquale.esposito@unige.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Injury incidence (time frame: Collection of retrospective data from 2016). 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 29 Nov 2023.