FOUR-Based Modification of ICU Severity Scores

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorAl-Nahrain University

About this trial

The goal of this observational study is to evaluate whether the Full Outline of UnResponsiveness (FOUR) score can replace the Glasgow Coma Scale (GCS) as the neurologic component of established intensive care unit (ICU) severity scoring systems and to derive and validate modified APACHE, SAPS, MODS, LODS, and SOFA models incorporating the FOUR score in critically ill adult patients.

The main questions it aims to answer are:

Does replacing the GCS with the FOUR score provide comparable or improved discrimination for in-hospital mortality across established ICU severity scoring systems? Can FOUR-based modifications of APACHE, SAPS, MODS, LODS, and SOFA be successfully derived and validated with adequate discrimination, calibration, and overall predictive performance? Do the modified FOUR-based models demonstrate predictive performance comparable to or different from the corresponding original GCS-based models?

Researchers will compare the performance of the modified FOUR-based models with their original GCS-based counterparts to determine whether substitution of the FOUR score provides valid and clinically useful risk prediction in critically ill adults.

Participants will not receive an experimental intervention. Data routinely collected during ICU care will be used to:

Calculate the original GCS-based APACHE, SAPS, MODS, LODS, and SOFA scores. Replace the GCS component with the FOUR score and derive the corresponding modified models.

Evaluate and validate the predictive performance of the original and modified models using measures of discrimination, calibration, and overall predictive accuracy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients for whom sufficient clinical and physiological data are available to calculate the original APACHE, SAPS, MODS, LODS, and SOFA scores.

Patients with a documented mortality outcome.

Disqualifiers

Patients transferred from another hospital after initial resuscitation.

Patients who died before the required initial clinical assessment.

Trial population

The study population will be drawn from patients admitted to the intensive care unit(s) of a tertiary-care teaching hospital in Baghdad, Iraq, during the predefined study period. The source population will include consecutive ICU admissions managed under routine clinical care, representing a broad spectrum of acute medical, surgical, traumatic, neurological, and other critical illnesses. Routinely collected clinical and physiological data from eligible ICU admissions will be used for the derivation and validation of modified severity-scoring models.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

In hospital mortality

Mortality (death) during hospitalization

Time frame
In-Hospital Phase (average of 20 days through discharge)

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: