Red Cell Distribution Width Versus Presepsin (Soluble CD14) as a Prognostic Marker in Critically-ill Sepsis Patients

Completed

• Conditions: Sepsis
• Interventions: Diagnostic Test: Red Cell Distribution Width (RDW); Diagnostic Test: Presepsin (sCD14-ST)

• Registration Number: NCT03796715
• Lead Sponsor: Ain Shams University

Brief Summary

Presepsin (soluble CD14 subtype) is a novel marker with growing body of evidence supporting its accuracy and value for the diagnosis of sepsis. Patients with sepsis showed higher Prsepsin levels compared to those with SIRS. In addition the increase in Prsepsin levels correlates well with sepsis severity. Red cell distribution width variations are increased in a variety of medical conditions such as congestive heart failure, acute myocardial infarction, pulmonary embolism, pneumonia, critical illness, and cardiac arrest , and is a predictor of mortality in the general population. we aim to compare between Presepsin (soluble CD14) and RDW as prognostic markers in critically-ill patients with sepsis.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2018-11-20
• Study Completion: 2018-12-24
• Status Verified: 2019-01
• Study First Submitted: 2019-01-01
• Study First Submitted QC: 2019-01-07
• Last Update Submitted: 2019-01-07
• Study First Posted: 2019-01-08
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Male or female aged 18 65 years.
• Appropriate clinical data to enable classification into sepsis or SIRS according to Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
• Written informed consent by the patient or guardian

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Exclusion Criteria

• No informed consent
• Renal failure
• Liver failure
• Hematologic diseases
• Neutropenia
• Malignancy
• Chemotherapy during the previous 90 days.
• Patients using antibiotics at presentation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Red Cell Distribution Width (RDW)	Red Cell Distribution Width (RDW)	RDW was assessed as part of complete blood count analysis using SYSMEX XN-550 automated analyzer
Presepsin (sCD14-ST)	Presepsin (sCD14-ST)	Presepsin analysis was done by utilising Elisa technique using kits from (MyBioSource, San Diego, CA 92195-3308 USA)

Primary Outcome Measures

Name	Time	Method
Mortality during intensive care unit stay	28 days

Secondary Outcome Measures

Name	Time	Method
Need for readmission to ICU	assessed up to 3 months
Ventilatory support duration	assessed up to 3 months
Number of participants who need inotropic or vasopressor support	assessed up to 3 months
Length of ICU stay	assessed up to 3 months
Number of participants who need renal replacement therapy	assessed up to 3 months
Transfusion requirements (blood and blood products)	assessed up to 3 months

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt