Evaluation of Serum Procalcitonin in Critically Ill Patients With Suspected Sepsis

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03506152
• Other study ID #: RRG # 2013-06
• Status: Completed
• First received: April 12, 2018
• Last updated: April 23, 2018
• Start date: January 1, 2014
• Est. completion date: December 3, 2015

Study information

• Verified date: April 2018
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 3, 2015
• Est. primary completion date: December 3, 2015
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Sepsis
• Toxemia

Intervention

Diagnostic Test:
• Serum Procalcitonin
Seven ml of blood was drawn in gel separator tubes within 24 hours of admission in ICU for Procalcitonin determination

Locations

Country	Name	City	State
Pakistan	Sibtain Ahmed	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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