NCT03506152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

1.9 years

First QC Date

April 12, 2018

Last Update Submit

April 23, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Culture positive

Diagnostic Test: Serum Procalcitonin

Culture negative

Diagnostic Test: Serum Procalcitonin

Interventions

Serum ProcalcitoninDIAGNOSTIC_TEST

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

Culture negativeCulture positive

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with suspected sepsis were recruited

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sibtain Ahmed

Karachi, Sindh, 71000, Pakistan

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

April 12, 2018

First Posted

April 24, 2018

Study Start

January 1, 2014

Primary Completion

December 3, 2015

Study Completion

December 3, 2015

Last Updated

April 24, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations