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NCT Number: NCT03796715

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

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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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University Hospitals

Cairo, 11591, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Red Cell Distribution Width (RDW)

Diagnostic Test

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

Presepsin (sCD14-ST)

Diagnostic Test

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

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 8, 2019
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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