Assessment of Red Cell Distribution Width's Prognostic Ability in Septic Intensive Care Unit Patients

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Diagnostic test: Prognostic biomarker as Red Cell Distribution Width

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11111
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Farah H Barsoum, M.B.B.CH, Anesthesia resident Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 14, 2024

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: prognosis; sepsis; intensive care units; inflammatory markers; Red Cell Distribution Width
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: FMASU MS85/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all data will be shared once study is completed
• IPD Sharing Access Criteria: free
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No