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CompletedNCT07775911Updated Aug 20, 2026

RDW:MCHC as a Pragmatic Adjunct to SOFA Score in ICU Mortality Assessment

An observational study in Critical Illness, sponsored by Sohag University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Sohag University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study summary

Critical illness represents a complex pathophysiological state characterized by systemic inflammation, oxidative stress, immune dysregulation, and progressive multiorgan dysfunction. In the Intensive Care Unit (ICU) setting, accurate and timely risk stratification remains paramount for optimizing patient outcomes, guiding therapeutic decision-making, and ensuring appropriate allocation of limited healthcare resources .Red cell distribution width (RDW), a quantitative measure of anisocytosis, has emerged as a powerful independent predictor of adverse outcomes across diverse clinical contexts, including sepsis, cardiovascular disease, and general ICU populations . Elevated RDW reflects dysregulated erythropoiesis and is mechanistically linked to chronic inflammation, oxidative stress, nutritional deficiencies, and impaired hematopoietic progenitor cell function .Mean corpuscular hemoglobin concentration (MCHC) represents the average hemoglobin concentration within erythrocytes and provides valuable information regarding red blood cell integrity, hemoglobin synthesis, and oxygen-carrying capacity. Reduced MCHC values are observed in conditions associated with impaired hemoglobin production, while elevated values may indicate hemolysis or red cell dehydration .Emerging evidence suggests that composite hematological ratios may enhance predictive performance compared to individual parameters by integrating complementary physiological information. The RDW:MCHC ratio is a novel biomarker that combines variability in red cell size with hemoglobin concentration, potentially offering a more comprehensive reflection of the underlying pathophysiological derangements characteristic of critical illness

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Conditions studied

  • Critical Illness

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All consecutive adult patients (≥18 years) admitted to the Intensive Care Unit (ICU) at Sohag University Hospital, a tertiary care referral hospital, who meet the eligibility criteria. The study population includes both obstetric (pregnant and postpartum) and non-obstetric (non-pregnant) critically ill patients. Patients with documented hematological malignancies or recent blood transfusion (within 7 days prior to ICU admission) are excluded.

Inclusion criteria

    • ICU stay of at least 24 hours duration

      • Available complete blood count (CBC) parameters at the time

        • pregnant women at any gestational age and postpartum women (up to 6 weeks following delivery) are eligible
        • Adult patients (≥18 years)

Exclusion criteria

Exclusion Criteria:

    • Documented hematological malignancies (including leukemia, lymphoma, and myelodysplastic syndromes)

      • Recent blood transfusion (within 7 days prior to ICU admission)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • obestatric ICU group
  • non obestatric ICU group
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What researchers measure

Primary outcomes

  1. 1. ICU Mortality

    All-cause mortality during ICU stay, assessed through prospective follow-up from admission until discharge or death

    Time frame: From ICU admission to ICU discharge or death, up to 90 days

Secondary outcomes

  1. ICU Length of Stay

    Duration of intensive care unit admission measured in days from ICU admission until ICU discharge.

    Time frame: From ICU admission to ICU discharge (assessed up to 90 days)

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Study locations

1 site
  • Sohag university .faculty of medicine .internal medicine department
    Sohag, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT07775911
Lead sponsor
Sohag University
Responsible party
sara kasem (lecutrer of internal medicine, Sohag University) — Principal investigator
First posted
Aug 20, 2026
Start date
Jul 5, 2026
Primary completion
Aug 1, 2026
Completion
Aug 5, 2026
Last update
Aug 20, 2026

Study contacts

marwa ELzanaty Elsayed, PHD
principal investigator · Sohag university .faculty of medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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