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CompletedNCT03796715Updated Jan 8, 2019

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

An observational study in Sepsis, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-01-08.

Sponsored by Ain Shams University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Sepsis

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Keywords

  • sepsis
  • presepsin
  • red cell distribution width
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 200 is above the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • 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)

  • 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)

Interventions

  • Diagnostic testRed Cell Distribution Width (RDW)

    A total of 100 sepsis patients, Red Cell Distribution Width (RDW) was used as prognostic marker.

  • Diagnostic testPresepsin (sCD14-ST)

    : A total of 100 sepsis patients, Presepsin (sCD14-ST) was used as prognostic marker.

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What researchers measure

Primary outcomes

  1. Mortality during intensive care unit stay

    Time frame: 28 days

Secondary outcomes

  1. Length of ICU stay

    Time frame: assessed up to 3 months

  2. Need for readmission to ICU

    Time frame: assessed up to 3 months

  3. Ventilatory support duration

    Time frame: assessed up to 3 months

  4. Number of participants who need renal replacement therapy

    Time frame: assessed up to 3 months

  5. Number of participants who need inotropic or vasopressor support

    Time frame: assessed up to 3 months

  6. Transfusion requirements (blood and blood products)

    Time frame: assessed up to 3 months

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Study locations

1 site
  • Ain Shams University Hospitals
    Cairo, 11591, Egypt
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03796715
Lead sponsor
Ain Shams University
Responsible party
Ahmed Elsayed (Principal Investigator, Ain Shams University) — Principal investigator
First posted
Jan 8, 2019
Start date
Aug 1, 2018
Primary completion
Nov 20, 2018
Completion
Dec 24, 2018
Last update
Jan 8, 2019

Study contacts

Ahmed Elsayed
principal investigator · Ain Shams University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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