Applying Artificial Intelligence to Identify Subphenotype... | NCT06471101

Studies
Applying Artificial Intelligence to Identify Subphenotypes of Acute Kidney Injury in Mexican Patients With Severe COVID-19

NCT06471101

Sponsor

Instituto Nacional de Enfermedades Respiratorias

Status

Completed

Last Update Posted

Jun 24, 2024Actual

Enrollment

2,934Actual

Phase

Not provided

Conditions

COVID-19
Acute Kidney Injury

Interventions

clusters

Countries

Mexico

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

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2024Actual

Primary Completion Date

Jun 18, 2024Actual

Completion Date

Jun 18, 2024Actual

First Submitted Date

Jun 18, 2024

First Submission Date that Met QC Criteria

Jun 20, 2024

First Posted Date

Jun 24, 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

Jun 20, 2024

Last Update Posted Date

Jun 24, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elizabeth Santiago Del Angel, Ph D. in computer science, Instituto Nacional de Enfermedades RespiratoriasPrincipal Investigator

Lead Sponsor

Instituto Nacional de Enfermedades RespiratoriasOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 was to identify subphenotypes of acute kidney injury patients with COVID-19, and the investigators analyzed their impact on mortality. The study included demographic and clinical variables of the participants. The implementation of Machine Learning algorithms and Artificial Intelligence methods are used, and some specific implementations were designed for the analysis, where each group was characterized by traditional statistical methods.

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

2,934Actual

Name	Type	Description	Arm Group Labels	Other Names
clusters	Diagnostic Test	clustering

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subphenotypes of acute kidney injury in patients	Number of acute kidney injury subphenotypes in patients with COVID-19	Through study completion, an average of one month

Secondary Outcomes

Measure	Description	Time Frame
Mortality of acute kidney injury patients	Differences between mortality rates in acute kidney injury subphenotypes of patients with COVID-19	Through study completion, an average of one month
Severity of acute kidney injury patients

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients older than 15 years old, hospitalized, and with severe acute respiratory syndrome (SARS-CoV-2) positive confirmation.

Exclusion Criteria:

Patients who did not have at least 1 creatinine measurement.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with acute kidney injury and COVID-19

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Nacional de Enfermedades Respiratorias		Mexico City		14080	Mexico

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
D000086382	COVID-19
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided