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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796715
• Other study ID #: FMASU R76/2018
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: December 24, 2018

Study information

• Verified date: January 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 24, 2018
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality during intensive care unit stay		28 days
Secondary	Length of ICU stay		assessed up to 3 months
Secondary	Need for readmission to ICU		assessed up to 3 months
Secondary	Ventilatory support duration		assessed up to 3 months
Secondary	Number of participants who need renal replacement therapy		assessed up to 3 months
Secondary	Number of participants who need inotropic or vasopressor support		assessed up to 3 months
Secondary	Transfusion requirements (blood and blood products)		assessed up to 3 months