NCT06857188

Brief Summary

The assessment of AI -based prediction models in detecting AKI early in critically ill patients. Specifically, the aim is to evaluate the model's ability to predict the onset of AKI before it clinically manifests allowing for early interventions

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 14, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

10 months

First QC Date

February 26, 2025

Last Update Submit

May 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The assessment of AI -based prediction models in detecting AKI early in critically ill patients.

    assessment of the ability of the AI based model to detect AKI in critically ill patients by evaluating the model ability to predict the onset of early AKI before it is clinically manifested for early interventions . this will be done by generating an AKI risk score by the model for each patient. Outcomes are tracked and the model is updated periodically based on new patient data to improve accuracy and reliability

    1 year

Secondary Outcomes (1)

  • assessment of other aspects

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Baseline characteristics, including demographic information, comorbidities, vital signs, laboratory results, medical interventions, disease severity scores, etc. were carefully reviewed and collected. The definitions of comorbidities including congestive heart failure, peptic ulcer disease, myocardial infarction, peripheral vascular disease, diabetes, dementia, chronic pulmonary disease, rheumatic disease, cerebrovascular disease, cancer, paraplegia, liver disease, renal disease, and acquired immunedeficiency syndrome. Severe organ failure due to ineffective immune response to infection was identified as sepsis. During the first 24 h when the patient was admitted to the ICU, the average values of the patient's vital signs (heart rate, mean arterial pressure, respiration rate, body temperature, and SpO2) were measured,, and the highest value of the biochemical laboratory tests (hematocrit, hemoglobin, platelets, white blood cell, blood urea nitrogen, international normalized ratio, Scr,

You may qualify if:

  • All adult (aged 18 years old and older) patients who were admitted to the ICU were included in this study.

You may not qualify if:

  • patients under 18 years old
  • End-stage renal disease
  • Acute Kidney Injury at ICU admission
  • Inability to obtain sufficient clinical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Alaa El-Dein ElMoneim Sayed, professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Kareem Sherif Mosabah, Assistant lecturer

CONTACT

Radwa Awad Abd El Hafez, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant lecturer of critical care

Study Record Dates

First Submitted

February 26, 2025

First Posted

March 4, 2025

Study Start

May 14, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

May 16, 2025

Record last verified: 2025-05