Diagnostic and Prognostic Roles of Procalcitonin and Highly Sensitive C-Reactive Protein in Early Detection of Burn Sepsis

August 24, 2026 updated by: Riwina Adel, Mansoura University
This study aimed to evaluate the value of procalcitonin and highly sensitive c-reactive protein as biomarkers for early detection of sepsis in patients with major burns.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Severe burn injuries can cause a marked inflammatory stress response. As the inflammatory state progresses, pro-inflammatory cytokines are continuously released.

C reactive protein (CRP) is closely related to the systemic inflammation in its acute phase, as CRP binds to the damaged cell membranes that associates burn injuries and contributes to the associated inflammatory response.

Procalcitonin (PCT) a precursor protein for calcitonin, which is synthesized by thyroid C-cells, is yet another biomarker valuable in the sepsis diagnosis.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egypt, 35516
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This is prospective study will include a total number of 30 patients with major burn. These patients will be admitted to Plastic, Reconstructive and Burn surgery center at Mansoura University from July 2025 to July 2026.

Description

Inclusion Criteria:

  • Age from 3 years to 65 years.
  • Both sexes.
  • Patients with major burn (2nd and 3rd degrees of burn).

Exclusion Criteria:

  • Patients with unrealistic expectations.
  • Patients with inhalational burn injury.
  • Patients with uncompensated chronic disease e.g. hepatic, renal.
  • Patients with mental or psychological troubles affecting the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Patients with major burn (2nd and 3rd degrees of burn)
Diagnostic test: Measurement of Procalcitonin level
Two samples was collected from each patient, one on admission or within the 1st 24 hours of burn and the 2nd were after 3 days.
Diagnostic test: Measurement of c-reactive protein level
Two samples was collected from each patient, one on admission or within the 1st 24 hours of burn and the 2nd were after 3 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of c-reactive protein level
Time Frame: 5 days of burn injury
Two samples was collected from each patient, one on admission or within the 1st 24 hours of burn and the 2nd were after 3 days.
5 days of burn injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of procalcitonin level
Time Frame: 5 days of burn injury
Two samples were collected from each patient, one on admission or within the 1st 24 hours of burn and the 2nd were after 3 days.
5 days of burn injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Actual)

July 1, 2026

Study Completion (Actual)

July 1, 2026

Study Registration Dates

First Submitted

August 24, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD.25.08.1017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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