Evaluation of Serum Procalcitonin in Critically Ill Patients With Suspected Sepsis

NCT ID: NCT03506152

Last Updated: 2018-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 103 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2015-12-03

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.

Conditions

Sepsis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Culture positive

Serum Procalcitonin

Intervention Type: DIAGNOSTIC_TEST

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

Culture negative

Serum Procalcitonin

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Serum Procalcitonin

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Sibtain Ahmed

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sibtain Ahmed

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

RRG # 2013-06

Identifier Type: -

Identifier Source: org_study_id