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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03506152
Other study ID # RRG # 2013-06
Secondary ID
Status Completed
Phase
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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