Critical IllnessNCT07775911
RDW:MCHC as a Pragmatic Adjunct to SOFA Score in ICU Mortality Assessment
An observational study of Critical Illness, run by Sohag University at 1 site in Egypt.
Trial summary
Critical illness represents a complex pathophysiological state characterized by systemic inflammation, oxidative stress, immune dysregulation, and progressive multiorgan dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jul 2026to 5 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- • 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)
Who cannot join
- • Documented hematological malignancies (including leukemia, lymphoma, and myelodysplastic syndromes)
- Recent blood transfusion (within 7 days prior to ICU admission)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Sohag university .faculty of medicine .internal medicine department
Sohag
About this study
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
- Conditions
- Critical Illness
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| obestatric ICU group | Not described | |
| non obestatric ICU group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. ICU Mortality
All-cause mortality during ICU stay, assessed through prospective follow-up from admission until discharge or death
Measured: 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.
Measured: From ICU admission to ICU discharge (assessed up to 90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start5 Jul 2026
- Primary completion1 Aug 2026
- Study completion5 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara kasem, Sohag University
- Investigators
- marwa ELzanaty Elsayed, PHD, Principal investigator, Sohag university .faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775911
- Sponsor's protocol ID
- Soh-Med-26-7--5PD
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RDW:MCHC as a Pragmatic Adjunct to SOFA Score in ICU Mortality Assessment
- ClinicalTrials.gov ID
- NCT07775911
- Acronym / sponsor ID
- Soh-Med-26-7--5PD
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 5 Jul 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 5 Aug 2026 (actual)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obestatric ICU group | – | – |
| non obestatric ICU group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- • ICU stay of at least 24 hours duration
Key exclusion criteria (2 listed)
- • Documented hematological malignancies (including leukemia, lymphoma, and myelodysplastic syndromes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1. ICU Mortality
Time frame: From ICU admission to ICU discharge or death, up to 90 days
All-cause mortality during ICU stay, assessed through prospective follow-up from admission until discharge or death
1 secondary outcome
ICU Length of Stay
Time frame: From ICU admission to ICU discharge (assessed up to 90 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
marwa ELzanaty Elsayed, PHD principal investigator
Sohag university .faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Sohag University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 20 Aug 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. ICU Mortality (time frame: From ICU admission to ICU discharge or death, up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2026.