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ICU Mortality (Survival Rate)FOUR-ICUNCT07832773

FOUR-Based Modification of ICU Severity Scores

An observational study of ICU Mortality (Survival Rate), run by Al-Nahrain University at 1 site in Iraq.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
ICU Mortality (Survival Rate)
How many people
2,000 participants
Where
1 siteIraq
Study dates
1 Nov 2026to 15 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study 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.

Who may be able to join

  • 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.

Who cannot join

  • Patients transferred from another hospital after initial resuscitation.
  • Patients who died before the required initial clinical assessment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Abdulillah R. Khamees, MBBCH contact

07838571013

abdulilah.r.khamis@gmail.com

Iraq1 site
  • College of Medicine - Al-Nahrain University

    Baghdad, Baghdad Governorate, 10011

    Abdulillah R. Khamees, MBBCH, 07838571013, abdulilah.r.khamis@gmail.com

    abdulilah.r.khamis@gmail.com

Other trials in Iraq

About this study

Official title: Replacing GCS With FOUR in ICU Severity Scores: Derivation and Validation of Modified APACHE, SAPS, MODS, LODS, and SOFA Models

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:

Read more

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.

Read the detailed description

Intensive care units (ICUs) are highly complex, resource and technology intensive settings. During the 1970s and 1980s, increasing intensive care costs and poor outcomes among patients with multiple organ failure created a need for tools to measure illness severity and patient outcomes. Intensive care unit mortality varies considerably worldwide, with rates of 16.2% in large international study and 19.1% in a European cohort study, while higher mortality was reported in developing countries, Ethiopia (39.06%) and Iraq (29.8%).

The Glasgow Coma Scale (GCS) assesses impaired consciousness using eye opening, verbal, and motor responses and is widely used for assessment, triage, monitoring, and communication among healthcare professionals. It has several limitations, verbal component cannot be assessed reliably in patients who are intubated, pharmacologically sedated, or unable to speak, limiting the use of the total score for prognosis. Also has limitation in evaluation patients with concomitant head and spinal cord injury. Drug and alcohol intoxication can also affect GCS assessment and should be considered when interpreting scores. In addition, Aphasia, paralysis, neuromuscular weakness, and spinal injuries may impair verbal or motor responses independently of consciousness, while painful stimuli can complicate scoring in polytrauma patients. Its reliability depends on assessor training, the patient's consciousness level, and the type of stimulus used.

The Full Outline of UnResponsiveness (FOUR) score consisting of four components: eye response, motor response, brainstem reflexes, and respiration, with each component assigned a maximum score of 4. It showed excellent interrater reliability (weighted kappa = 0.82), and provide greater neurological detail and identification of severe impairment than GCS. In non-traumatic patients, FOUR score showed better mortality discrimination than GCS (AUROC 0.799 vs. 0.731), and offers advantages in intubated patients because it evaluates brainstem reflexes and respiratory patterns. FOUR also showed better mortality prediction than GCS in traumatic brain injury, neurosurgical, and acute brain-injury patients, with AUROC values of 0.93 vs. 0.89, 0.768 vs. 0.699, and 0.835 vs. 0.772, respectively.

The Acute Physiology and Chronic Health Evaluation (APACHE) assess risk of in-hospital by using pre-admission health status and 34 physiological variables collected during the first 24 hours of ICU admission. The Acute Physiology and Chronic Health Evaluation II (APACHE II) uses 12 physiological variables, along with age and previous health status, to calculate a score from 0-71, with higher scores indicating greater illness severity and mortality risk. APACHE III incorporated over 100 variables, while APACHE IV added further clinical factors and enabled prediction of hospital mortality and ICU length of stay.

The Simplified Acute Physiology Score (SAPS) includes14 physiological variables collected during the first 24 hours of ICU admission to provides a simple measure of the risk of death among critically ill patients. The Simplified Acute Physiology Score II (SAPS II) provide an objective assessment of illness severity and an estimate of hospital mortality among critically ill patients. SAPS II involve 17 variables, including 12 physiological measurements, age, type of ICU admission, and three underlying disease conditions: acquired immunodeficiency syndrome, metastatic cancer, and hematologic malignancy. SAPS 3, incorporated 20 variables and provided region-specific mortality prediction for international use.

The Multiple Organ Dysfunction Score (MODS) assesses six organ systems using PaO₂/FiO₂ ratio, creatinine, bilirubin, platelet count, Glasgow Coma Scale, and pressure-adjusted heart rate. Each variable is scored from 0-4, producing a total score of 0-24, with higher values associated with increased ICU mortality.

The Sequential Organ Failure Assessment (SOFA) assesses organ dysfunction and illness severity, particularly in sepsis. It evalutes six organ systems: respiratory function using the PaO₂/FiO₂ ratio, coagulation using platelet count, liver function using serum bilirubin, cardiovascular function according to mean arterial pressure and vasopressor requirements, central nervous system function using the Glasgow Coma Scale, and renal function using serum creatinine or urine output. The worst daily values are scored from 0-4, giving a total of 0-24, with higher scores indicating greater organ dysfunction. SOFA is practical for bedside use and is mainly used to quantify organ dysfunction, evaluate treatment effects, and monitor progression, with higher scores are associated with increased mortality in sepsis.

The Logistic Organ Dysfunction System (LODS) was derived from 12 countries. It evaluates six organ systems using variables related to neurologic, cardiovascular, renal, pulmonary, hematologic, and hepatic function, producing a score from 0-22. It showed good discrimination, with AUROC values of 0.843 in the development sample and 0.850 in the validation sample. It can also accurately describe the progression of illness when applied on a daily basis.

Trauma severity scoring systems help assess injury severity, guide triage, and predict patient outcomes. It can be divided into anatomical, physiological, and combined scores each with advantages and disadvantages. Anatomical scores describe the injuries recorded by clinical examination, imaging, surgery, or autopsy. While Physiologic Scores describe changes due to a trauma and translated by changes in vital signs and consciousness. Combining anatomical and physiological scores may provide better prediction of mortality in severely injured ICU patients.

The Trauma and Injury Severity Score (TRISS) combines Revised Trauma Score, Injury Severity Score, and patient age, to improve prediction of trauma outcomes. The Rapid Emergency Medicine Score (REMS) is a physiological score derived from APACHE II and provides rapid risk stratification using age, mean arterial pressure, respiratory rate, pulse rate, oxygen saturation, and Glasgow Coma Scale. The modified REMS (mREMS) substituting systolic blood pressure for mean arterial pressure, reducing the weighting of age, and increasing the weighting of GCS. It showed an AUROC of 0.967 for predicting in-hospital mortality.

Neurologic status is central to ICU prognosis and risk adjustment, but the Glasgow Coma Scale (GCS) has practical limitations because its verbal component is difficult or impossible to assess in intubated or mechanically ventilated patients. The FOUR score was developed to address this by using eye, motor, brainstem reflexes, and respiration, and it has shown feasibility and reliable use in emergency and intensive care settings. Prior studies suggest FOUR is often at least comparable to GCS for mortality prediction and may perform better in some ICU cohorts, especially when verbal assessment is compromised.

Despite this promise, the available evidence largely evaluates FOUR as a standalone score, not as a direct replacement for GCS inside established ICU severity models. No retrieved studies identified substantive derivation, recalibration, or external validation of FOUR-substituted versions of APACHE, SAPS, MODS, or LODS. The only identified model-level substitution evidence was for SOFA, and it was unfavorable: a FOUR-based modification did not improve mortality prediction and showed lower AUROC than the standard GCS-based SOFA. This leaves a clear methodological gap in whether FOUR can be validly integrated into legacy severity scores rather than only used as an independent neurologic assessment. Accordingly, this study aims to determine whether FOUR can replace GCS in established ICU severity scores and whether such substitution supports the derivation and validation of modified APACHE, SAPS, MODS, LODS, and SOFA models.

Keywords
ICU Scoring Systems, GCS, FOUR Score, APACHE, SAPS, MODS, LODS, SOFA
Medical subject headings
Multiple Organ Failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In hospital mortality

    Mortality (death) during hospitalization

    Measured: In-Hospital Phase (average of 20 days through discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion15 Dec 2027 (estimated)

Resources

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
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07832773
Sponsor's protocol ID
UNCOMIRB202609015
Acronym
FOUR-ICU
Status last verified
Sep 2026
First submitted
16 Sep 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kramer AA, Wijdicks EF, Snavely VL, Dunivan JR, Naranjo LL, Bible S, Rohs T, Dickess SM. A multicenter prospective study of interobserver agreement using the Full Outline of Unresponsiveness score coma scale in the intensive care unit. Crit Care Med. 2012 Sep;40(9):2671-6. doi: 10.1097/CCM.0b013e318258fd88.

    PubMed 22732282
  • Wijdicks EF, Kramer AA, Rohs T Jr, Hanna S, Sadaka F, O'Brien J, Bible S, Dickess SM, Foss M. Comparison of the Full Outline of UnResponsiveness score and the Glasgow Coma Scale in predicting mortality in critically ill patients*. Crit Care Med. 2015 Feb;43(2):439-44. doi: 10.1097/CCM.0000000000000707.

    PubMed 25393699
  • Ramazani J, Hosseini M. Comparison of full outline of unresponsiveness score and Glasgow Coma Scale in Medical Intensive Care Unit. Ann Card Anaesth. 2019 Apr-Jun;22(2):143-148. doi: 10.4103/aca.ACA_25_18.

    PubMed 30971594
  • Telles GP, Ferreira IBB, Carvalho de Menezes R, do Carmo TA, David Pugas PL, Marback LF, Arriaga MB, Fukutani KF, Neto LP, Agareno S, Akrami KM, Filgueiras Filho NM, Andrade BB. Comparison of a modified Sequential Organ Failure Assessment Score using RASS and FOUR. PLoS One. 2020 Feb 21;15(2):e0229199. doi: 10.1371/journal.pone.0229199. eCollection 2020.

    PubMed 32084199
  • Ferreira AM, Sakr Y. Organ dysfunction: general approach, epidemiology, and organ failure scores. Semin Respir Crit Care Med. 2011 Oct;32(5):543-51. doi: 10.1055/s-0031-1287862. Epub 2011 Oct 11.

    PubMed 21989690
  • Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA. 1993 Dec 22-29;270(24):2957-63. doi: 10.1001/jama.270.24.2957.

    PubMed 8254858
  • Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.

    PubMed 3928249
  • Pellathy TP, Pinsky MR, Hravnak M. Intensive Care Unit Scoring Systems. Crit Care Nurse. 2021 Aug 1;41(4):54-64. doi: 10.4037/ccn2021613.

    PubMed 34333619
  • Knaus WA, Zimmerman JE, Wagner DP, Draper EA, Lawrence DE. APACHE-acute physiology and chronic health evaluation: a physiologically based classification system. Crit Care Med. 1981 Aug;9(8):591-7. doi: 10.1097/00003246-198108000-00008.

    PubMed 7261642
  • Momenyan S, Mousavi SM, Dadkhahtehrani T, Sarvi F, Heidarifar R, Kabiri F, Mohebi E, Koohbor M. Predictive Validity and Inter-Rater Reliability of the Persian Version of Full Outline of Unresponsiveness Among Unconscious Patients with Traumatic Brain Injury in an Intensive Care Unit. Neurocrit Care. 2017 Oct;27(2):229-236. doi: 10.1007/s12028-016-0324-0.

    PubMed 28054286
  • Chen B, Grothe C, Schaller K. Validation of a new neurological score (FOUR Score) in the assessment of neurosurgical patients with severely impaired consciousness. Acta Neurochir (Wien). 2013 Nov;155(11):2133-9; discussion 2139. doi: 10.1007/s00701-013-1854-2. Epub 2013 Sep 8.

    PubMed 24013867
  • Sadaka F, Patel D, Lakshmanan R. The FOUR score predicts outcome in patients after traumatic brain injury. Neurocrit Care. 2012 Feb;16(1):95-101. doi: 10.1007/s12028-011-9617-5.

    PubMed 21845490
  • Karna R. Glasgow Coma Scale (GCS) Score and Full Outline of UnResponsiveness (FOUR) Score in Predicting Outcomes in Patients Admitted to the Medical Intensive Care Unit of Patan Hospital. Cureus. 2026 May 11;18(5):e108684. doi: 10.7759/cureus.108684. eCollection 2026 May.

    PubMed 42291990
  • Wijdicks EF, Bamlet WR, Maramattom BV, Manno EM, McClelland RL. Validation of a new coma scale: The FOUR score. Ann Neurol. 2005 Oct;58(4):585-93. doi: 10.1002/ana.20611.

    PubMed 16178024
  • Reith FC, Brennan PM, Maas AI, Teasdale GM. Lack of Standardization in the Use of the Glasgow Coma Scale: Results of International Surveys. J Neurotrauma. 2016 Jan 1;33(1):89-94. doi: 10.1089/neu.2014.3843. Epub 2015 Aug 12.

    PubMed 25951090

Questions about this trial

What is this clinical trial studying?

An observational study of ICU Mortality (Survival Rate), run by Al-Nahrain University at 1 site in Iraq.

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 2 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: opening soon, as of the sponsor's last update on 22 Sep 2026. 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 Iraq. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Abdulillah R. Khamees, MBBCH (07838571013, abdulilah.r.khamis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In hospital mortality (time frame: In-Hospital Phase (average of 20 days through discharge)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07832773, which also lists 23 linked publications.

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 22 Sep 2026.

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