Evaluation of Serum Procalcitonin in Critically Ill Patients With Suspected Sepsis

Prospective Evaluation of Serum Procalcitonin in Critically Ill Patients With Suspected Sepsis- Experience From a Tertiary Care Hospital in Pakistan

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Diagnostic test: Serum Procalcitonin

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 Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 71000
      • Sibtain Ahmed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with suspected sepsis were recruited

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Culture positive	Diagnostic test: Serum Procalcitonin; Seven ml of blood was drawn in gel separator tubes within 24 hours of admission in ICU for Procalcitonin determination
Culture negative	Diagnostic test: Serum Procalcitonin; Seven ml of blood was drawn in gel separator tubes within 24 hours of admission in ICU for Procalcitonin determination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of Procalcitonin	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).	one year

Collaborators and Investigators

• Sponsor: Aga Khan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 3, 2015
• Study Completion (Actual): December 3, 2015

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: RRG # 2013-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No