Evaluation of Serum Procalcitonin in Critically Ill Patients With Suspected Sepsis

Completed

• Conditions: Sepsis
• Interventions: Diagnostic Test: Serum Procalcitonin

• Registration Number: NCT03506152
• Lead Sponsor: Aga Khan University

Brief Summary

Procalcitonin is a promising marker of sepsis in critically ill patients. Procalcitonin have better diagnostic accuracy compared to White blood cell count and C - reactive protein. Investigators propose that adding Procalcitonin to the list of standard laboratory work up of critically ill patients with suspected sepsis could increase diagnostic accuracy leading to better patient care.

Detailed Description

Background: Sepsis is the leading cause of mortality in critically ill patients. Procalcitonin (PCT) is a promising marker for identification of bacterial sepsis. The aim of this study was to determine the diagnostic accuracy of serum PCT concentration in patients with suspected sepsis admitted to mixed medical-surgical Intensive care unit (ICU).

Material and Methods: A cross-sectional study conducted at section of Chemical Pathology, Department of Pathology and Laboratory Medicine and ICU. Patients with suspected sepsis were included, serum PCT cut off ≥0.5 ng /ml was taken for diagnosing sepsis. Diagnostic accuracy was measured in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) taking blood culture as gold standard. Furthermore, different cut offs were compared by using receiver operating characteristic curves (ROC). Data analysis was done on SPSS version.

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2015-12-03
• Study Completion: 2015-12-03
• Status Verified: 2018-04
• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-23
• Last Update Submitted: 2018-04-23
• Study First Posted: 2018-04-24
• Last Update Posted: 2018-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

1. Both male and female patients less than 70 and greater than 18 years of age
2. Patients full filling the sepsis definition (American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference)
3. Patients were recruited within 24 hour of ICU admission

Exclusion Criteria

1. Patients discharged before 24 hours
2. Patients who had blood transfusion before ICU stay
3. Patients with organ failure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Culture positive	Serum Procalcitonin	-
Culture negative	Serum Procalcitonin	-

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of Procalcitonin	one year	Diagnostic accuracy was measured in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) taking blood culture as gold standard. Furthermore, different cut offs were compared by using receiver operating characteristic curves (ROC).

Trial Locations

Locations (1)

Sibtain Ahmed; 🇵🇰 Karachi, Sindh, Pakistan