NCT03796715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 1, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

January 1, 2019

Last Update Submit

January 7, 2019

Conditions

Sepsis

Keywords

sepsispresepsinred cell distribution width

Outcome Measures

Primary Outcomes (1)

  • Mortality during intensive care unit stay

    28 days

Secondary Outcomes (6)

  • Length of ICU stay

    assessed up to 3 months

  • Need for readmission to ICU

    assessed up to 3 months

  • Ventilatory support duration

    assessed up to 3 months

  • Number of participants who need renal replacement therapy

    assessed up to 3 months

  • Number of participants who need inotropic or vasopressor support

    assessed up to 3 months

  • +1 more secondary outcomes

Study Arms (2)

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

Red Cell Distribution Width (RDW)DIAGNOSTIC_TEST

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

Red Cell Distribution Width (RDW)
Presepsin (sCD14-ST)DIAGNOSTIC_TEST

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

Presepsin (sCD14-ST)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Sepsis

Interventions

Erythrocyte Indices

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Ahmed Elsayed

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 1, 2019

First Posted

January 8, 2019

Study Start

August 1, 2018

Primary Completion

November 20, 2018

Study Completion

December 24, 2018

Last Updated

January 8, 2019

Record last verified: 2019-01

Locations

EG(1)