Comparison Between Interleukin 6 and Procalcitonin in Det... | NCT06915974

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

NCT06915974

Sponsor

Ain Shams University

Status

Recruiting

Last Update Posted

Apr 8, 2025Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Burns
Sepsis
Septic Shock
Death

Interventions

Interleukin 6

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2025Actual

Primary Completion Date

Jul 10, 2025Estimated

Completion Date

Jul 10, 2025Estimated

First Submitted Date

Feb 14, 2025

First Submission Date that Met QC Criteria

Apr 4, 2025

First Posted Date

Apr 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2025

Last Update Posted Date

Apr 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Interleukin 6	Diagnostic Test	Interleukin 6 and procalcitonin will be sampled for all patients on days 1, 3, 7, and 10	Burn ICU patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed H Elsayed, M.B.B.CH	Contact	+201016305451		AhmedHanyAbdelfatah@med.asu.edu.eg

Overall Officials

Name	Affiliation	Role
Ahmed H Elsayed, M.B.B.CH	Anaesthesia, intensive care, and pain management resident Ain Shams University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All data will be shared once the study is completed

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

Before 1/2026

Access Criteria

Free

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002056	Burns
D018805	Sepsis
D012772	Shock, Septic
D003643	Death

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation

Browse Leaves

Not provided

Browse Branches

Not provided