Comparison Between Interleukin 6 and Procalcitonin in Detecting Sepsis and Incidence of Mortality in Burn ICU Patients

April 4, 2025 updated by: Ain Shams University
The investigators will compare the efficacy of Interleukin-6 (IL-6) as a better indicator than procalcitonin in burn patients with sepsis or septic shock regarding success of treatment and early ICU discharge.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Interleukin 6 and procalcitonin will be sampled for all patients on days 1, 3, 7, and 10.

Treatment plan will be initiated to all patients according to the burn ICU protocol.

According to the lab results, interleukin 6 and procalcitonin will guide the investigators to take decisions regarding clinical improvement and ICU stay.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with acute burn admitted to burn ICU within 24 hours from the burn incidence.
  • patients with burn percentage of 25% to 50% of total body surface area
  • patients with second to third degree burns
  • ASA 1 and ASA 2 patients

Exclusion Criteria:

  • Burn percentage more than 50% or less than 25% of total body surface area
  • Having autoimmune diseases
  • Cancer patients
  • ASA 3 and ASA 4 patients

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Burn ICU patients
Interleukin 6 and procalcitonin will be sampled for all patients on days 1, 3, 7, and 10. Treatment plan will be initiated to all patients according to the burn ICU protocol.
Diagnostic test: Interleukin 6
Interleukin 6 and procalcitonin will be sampled for all patients on days 1, 3, 7, and 10
Other Names:
  • Procalcitonin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of sepsis and septic shock
Time Frame: From day 1 to day 10 in burn ICU
Prediction of occurrence of sepsis and septic shock
From day 1 to day 10 in burn ICU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of ICU stay
Time Frame: One month after ICU admission
Response to treatment and length of ICU stay for over one month
One month after ICU admission

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Ahmed H Elsayed, M.B.B.CH, Anaesthesia, intensive care, and pain management resident Ain Shams 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)

January 10, 2025

Primary Completion (Estimated)

July 10, 2025

Study Completion (Estimated)

July 10, 2025

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MS 10/2024/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be shared once the study is completed

IPD Sharing Time Frame

Before 1/2026

IPD Sharing Access Criteria

Free

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Sepsis

Clinical Trials on Interleukin 6

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe