Study of the Incidence and Prognosis of Intrahospital Acu... | NCT06697730

Studies
Study of the Incidence and Prognosis of Intrahospital Acute Kidney Injury

NCT06697730

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Status

Active, not recruiting

Last Update Posted

Mar 27, 2026Actual

Enrollment

43,000Estimated

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 25, 2025Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Nov 18, 2024

First Submission Date that Met QC Criteria

Nov 18, 2024

First Posted Date

Nov 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2026

Last Update Posted Date

Mar 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 charts.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

43,000Estimated

Label	Type	Description	Intervention Names
Hospitalized Patients		All patients hospitalized from 01/01/2019 to 12/31/2023.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of intra-hospital Acute Kidney Injury		From 01/01/2019 to 12/31/2023

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Acute Kidney Injury in different hospital wards		From 01/01/2019 to 12/31/2023
Association between Acute Kidney Injury development and major discharge diagnoses		From 01/01/2019 to 12/31/2023

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients hospitalised from 01/01/2019 to 31/12/2023
Availability of a Hospital Discharge Form
At least one serum creatinine (sCr) determination available

Exclusion Criteria:

Day-hospital admission
Discharge after an emergency room admission without hospital admission
Stage IV and V CKD

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico		Milan		20122	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided