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

NCT06847451 | Completed DMC

• 1 other identifier: FMASU MS85/2024
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

sepsis; intensive care units; Red Cell Distribution Width; inflammatory markers; prognosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison between Red Cell Distribution Width and other inflammatory markers as well as known scoring systems regarding their prognostic discriminative ability.

  28 days

Interventions

Prognostic biomarker as Red Cell Distribution Width DIAGNOSTIC_TEST

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

Also known as: C-reactive proteins, Total leukocytic count, Serum lactate, Sequential Organ Failure Assessment (SOFA) Score

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt, 11111, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples, urine samples, sputum samples, skin swabs.

MeSH Terms

Conditions

Sepsis

Interventions

Erythrocyte Indices

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Farah H Barsoum, M.B.B.CH

  Anesthesia resident Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: April 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 14, 2024
• Last Updated: March 7, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: free

Locations

EG (1)