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

NCT ID: NCT06847451

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2024-09-14

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.

Conditions

Sepsis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Prognostic biomarker as Red Cell Distribution Width

Assessment of prognostic value of Red Cell Distribution Width in septic intensive care unit patients for 28 days mortality.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

C-reactive proteins; Total leukocytic count; Serum lactate; Sequential Organ Failure Assessment (SOFA) Score

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Farah H Barsoum, M.B.B.CH

Role: PRINCIPAL_INVESTIGATOR

Anesthesia resident Ain Shams University

Locations

Ain Shams University

Cairo, Egypt, Egypt

Countries

Egypt

Other Identifiers

FMASU MS85/2024

Identifier Type: -

Identifier Source: org_study_id