SepsisNCT06847451
Assessment of Red Cell Distribution Width's Prognostic Ability in Septic Intensive Care Unit Patients
An observational study of Sepsis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Various biomarkers are used for predicting outcome from sepsis and septic shock, but single value doesn't give a clear-cut picture. This prospective observational study aims to approach the prognostic value of Red Cell Distribution Width for morbidity and mortality of intensive care unit patients with sepsis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Prognostic biomarker as Red Cell Distribution Width
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 14 Sep 2024
- How long will I take part?
- 28 Days
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients admitted to Ain Shams University hospital intensive care units who fulfill the criteria of sepsis and septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
Who may be able to join
- Age Group: all adult patients aged more than 18 Years old and less than 70 years old.
- Intensive care unit admitted patients with sepsis.
Who cannot join
- Patients less than 18 years old and more than 70 years old.
- Patients with known hematological disease (e.g., leukemia, myelodysplastic syndrome), human immunodeficiency virus (HIV) infection or any immunosuppressant usage history.
- Patients having uncured malignancy.
- Patients who had a cardiac arrest event before ICU arrival.
- Patients who had recent (less than one week) blood transfusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Red Cell Distribution Width as a Prognostic Factor for Morbidity and Mortality of Intensive Care Unit Patients With Sepsis.
Various biomarkers are used for predicting outcome from sepsis and septic shock, but single value doesn't give a clear-cut picture. This prospective observational study aims to approach the prognostic value of Red Cell Distribution Width for morbidity and mortality of intensive care unit patients with sepsis. and this will be achieved by:
- Assessment of prognostic value of red cell distribution width in septic intensive care unit patients for 28 days mortality
- Comparison between red cell distribution width and other inflammatory markers as C-reactive protein and serum lactate as well as other scoring systems such as Sequential Organ Failure Assessment (SOFA) score, regarding their prognostic discriminative ability.
Read the detailed description
Critically ill patients admitted to Ain Shams University hospital intensive care units who fulfill the criteria of sepsis and septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) will be enrolled.
All patients will be resuscitated and managed according to Ain Shams University Hospitals protocol for sepsis and septic shock.
On admission, and after applying the exclusion and inclusion criteria, all clinical data will be collected from participants, which will mainly include patient's detailed medical history, site of infection, blood routine test, biochemical test, other inflammatory markers as C-reactive protein, Arterial blood gas for serum lactate count, and cultures samples according to source of infection. Red cell distribution width will be recorded for each patient on admission, then patients will be followed up for 28 days mortality.
Patient's morbidity will be defined by Sequential Organ Failure Assessment (SOFA) Score, it will be calculated and recorded on admission and will be followed up as well.
- Conditions
- Sepsis
- Being tested
- Prognostic biomarker as Red Cell Distribution Width
- Keywords
- sepsis, intensive care units, Red Cell Distribution Width, inflammatory markers, prognosis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prognostic biomarker as Red Cell Distribution WidthDiagnostic test
Also called C-reactive proteins, Total leukocytic count, Serum lactate, Sequential Organ Failure Assessment (SOFA) Score
Assessment of prognostic value of Red Cell Distribution Width in septic intensive care unit patients for 28 days mortality.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of prognostic value of Red Cell Distribution Width in septic Intensive care units patients for 28 days mortality.
Septic patients will be followed up at intensive care unit for a maximum duration of 28 days, patients will be divided then to survival and mortality groups and initial Red Cell Distribution Width value taken on admission will be reported for each individual to check relation between initial Red Cell Distribution Width reading and patients mortality. additionally, identifying a Red Cell Distribution Width cut-off value for both groups.
Measured: 28 days
Secondary outcomes (1)
Comparison between Red Cell Distribution Width and other inflammatory markers as well as known scoring systems regarding their prognostic discriminative ability.
Comparison between Red Cell Distribution and other inflammatory markers as C-reactive protein, Total leukocytic count, serum lactate as well as known scoring systems such as sequential organ failure assessment (SOFA) score regarding their prognostic discriminative ability for 28 days mortality.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Apr 2024
- Primary completion1 Sep 2024
- Study completion14 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farah H Barsoum, M.B.B.CH, Principal investigator, Anesthesia resident Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847451
- Sponsor's protocol ID
- FMASU MS85/2024
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data will be shared once study is completed
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Cell Distribution Width as a Prognostic Factor for Morbidity and Mortality of Intensive Care Unit Patients With Sepsis.
- ClinicalTrials.gov ID
- NCT06847451
- Acronym / sponsor ID
- FMASU MS85/2024
- Conditions
- Sepsis
- Keywords
- sepsis, intensive care units, Red Cell Distribution Width, inflammatory markers, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 14 Sep 2024 (actual)
- First posted
- 26 Feb 2025 (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.
Various biomarkers are used for predicting outcome from sepsis and septic shock, but single value doesn't give a clear-cut picture. This prospective observational study aims to approach the prognostic value of Red Cell Distribution Width for morbidity and mortality of intensive care unit patients with sepsis. and this will be achieved by:
- Assessment of prognostic value of red cell distribution width in septic intensive care unit patients for 28 days mortality
- Comparison between red cell distribution width and other inflammatory markers as C-reactive protein and serum lactate as well as other scoring systems such as Sequential Organ Failure Assessment (SOFA) score, regarding their prognostic discriminative ability.
Detailed description
Critically ill patients admitted to Ain Shams University hospital intensive care units who fulfill the criteria of sepsis and septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) will be enrolled.
All patients will be resuscitated and managed according to Ain Shams University Hospitals protocol for sepsis and septic shock.
On admission, and after applying the exclusion and inclusion criteria, all clinical data will be collected from participants, which will mainly include patient's detailed medical history, site of infection, blood routine test, biochemical test, other inflammatory markers as C-reactive protein, Arterial blood gas for serum lactate count, and cultures samples according to source of infection. Red cell distribution width will be recorded for each patient on admission, then patients will be followed up for 28 days mortality.
Patient's morbidity will be defined by Sequential Organ Failure Assessment (SOFA) Score, it will be calculated and recorded on admission and will be followed up as well.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted to Ain Shams University hospital intensive care units who fulfill the criteria of sepsis and septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
Key inclusion criteria (2 listed)
- Age Group: all adult patients aged more than 18 Years old and less than 70 years old.
- Intensive care unit admitted patients with sepsis.
Key exclusion criteria (5 listed)
- Patients less than 18 years old and more than 70 years old.
- Patients with known hematological disease (e.g., leukemia, myelodysplastic syndrome), human immunodeficiency virus (HIV) infection or any immunosuppressant usage history.
- Patients having uncured malignancy.
- Patients who had a cardiac arrest event before ICU arrival.
- Patients who had recent (less than one week) blood transfusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prognostic biomarker as Red Cell Distribution WidthAlso: C-reactive proteins, Total leukocytic count, Serum lactate, Sequential Organ Failure Assessment (SOFA) ScoreAssessment of prognostic value of Red Cell Distribution Width in septic intensive care unit patients for 28 days mortality. | Diagnostic test | – |
Primary outcome
Assessment of prognostic value of Red Cell Distribution Width in septic Intensive care units patients for 28 days mortality.
Time frame: 28 days
Septic patients will be followed up at intensive care unit for a maximum duration of 28 days, patients will be divided then to survival and mortality groups and initial Red Cell Distribution Width value taken on admission will be reported for each individual to check relation between initial Red Cell Distribution Width reading and patients mortality. additionally, identifying a Red Cell Distribution Width cut-off value for both groups.
1 secondary outcome
Comparison between Red Cell Distribution Width and other inflammatory markers as well as known scoring systems regarding their prognostic discriminative ability.
Time frame: 28 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 7 Mar 2025.
- Individual participant dataSharing planned: Yes. all data will be shared once study is completed
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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.
Farah H Barsoum, M.B.B.CH principal investigator
Anesthesia resident Ain Shams University
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 Sepsis, run by Ain Shams 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 2 inclusion and 5 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 7 Mar 2025. 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?
Assessment of prognostic value of Red Cell Distribution Width in septic Intensive care units patients for 28 days mortality. (time frame: 28 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 7 Mar 2025.