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

January 7, 2019 updated by: Ahmed Elsayed, Ain Shams University

Comparison of Red Cell Distribution Width Versus Presepsin (Soluble CD14) for Prognosis Assessment in Sepsis Patients Admitted to the Intensive Care Unit

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11591
        • Ain shams university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the general ICU with sepsis or septic shock of both sexes between 18 and 65 years of age.

Description

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Red Cell Distribution Width (RDW)
RDW was assessed as part of complete blood count analysis using SYSMEX XN-550 automated analyzer
Diagnostic test: Red Cell Distribution Width (RDW)
A total of 100 sepsis patients, Red Cell Distribution Width (RDW) was used as prognostic marker.
Presepsin (sCD14-ST)
Presepsin analysis was done by utilising Elisa technique using kits from (MyBioSource, San Diego, CA 92195-3308 USA)
Diagnostic test: Presepsin (sCD14-ST)
: A total of 100 sepsis patients, Presepsin (sCD14-ST) was used as prognostic marker.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality during intensive care unit stay
Time Frame: 28 days
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Ahmed Elsayed, Ain shams university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2018

Primary Completion (ACTUAL)

November 20, 2018

Study Completion (ACTUAL)

December 24, 2018

Study Registration Dates

First Submitted

January 1, 2019

First Submitted That Met QC Criteria

January 7, 2019

First Posted (ACTUAL)

January 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 8, 2019

Last Update Submitted That Met QC Criteria

January 7, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R76/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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