Clinical trial NCT06847451: Assessment of Red Cell Distribution Width's Prognostic Ability in Septic Intensive Care Unit Patients
Official title: Red Cell Distribution Width as a Prognostic Factor for Morbidity and Mortality of Intensive Care Unit Patients With Sepsis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: sepsis
intensive care units
Red Cell Distribution Width
inflammatory markers
prognosis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Age Group: all adult patients aged more than 18 Years old and less than 70 years old.
* Intensive care unit admitted patients with sepsis.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Assessment of prognostic value of Red Cell Distribution Width in septic Intensive care units patients for 28 days mortality.
timeFrame: 28 days
Secondary outcomes:
measure: Comparison between Red Cell Distribution Width and other inflammatory markers as well as known scoring systems regarding their prognostic discriminative ability.
timeFrame: 28 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Anesthesia resident Ain Shams University
name: Farah H Barsoum, M.B.B.CH
role: PRINCIPAL_INVESTIGATOR
References: