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

NCT06915974 | Recruiting DMC

• 1 other identifier: FMASU MS 10/2024/2025
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Burns; Sepsis; Septic Shock; Death

Outcome Measures

Primary Outcomes (1)

• Occurrence of sepsis and septic shock

  Prediction of occurrence of sepsis and septic shock

  From day 1 to day 10 in burn ICU

Secondary Outcomes (1)

• Length of ICU stay

  One month after ICU admission

Study Arms (1)

Burn ICU patients

EXPERIMENTAL

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

Interventions

Interleukin 6 DIAGNOSTIC_TEST

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

Also known as: Procalcitonin

Burn ICU patients

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Burns; Sepsis; Shock, Septic; Death

Condition Hierarchy (Ancestors)

Wounds and Injuries; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Ahmed H Elsayed, M.B.B.CH

  Anaesthesia, intensive care, and pain management resident Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed H Elsayed, M.B.B.CH

CONTACT

+201016305451; AhmedHanyAbdelfatah@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: April 8, 2025
• Study Start: January 10, 2025
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Before 1/2026
• Access Criteria: Free

Locations

EG (1)