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Completed

NCT Number: NCT03506152

Evaluation of Serum Procalcitonin in Critically Ill Patients With Suspected Sepsis

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sibtain Ahmed

Karachi, Sindh, 71000, Pakistan

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients discharged before 24 hours
  • Patients who had blood transfusion before ICU stay
  • Patients with organ failure

Treatment and study plan

Serum Procalcitonin

Diagnostic Test

Seven ml of blood was drawn in gel separator tubes within 24 hours of admission in ICU for Procalcitonin determination

Primary outcomes

  1. Diagnostic accuracy of Procalcitonin

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 24, 2018
Registry last updated
Apr 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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