BurnsNCT06915974
Comparison Between Interleukin 6 and Procalcitonin in Detecting Sepsis and Incidence of Mortality in Burn ICU Patients
A study testing Interleukin 6 in people with Burns and Sepsis, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Burns, Sepsis, Septic Shock
- What is being tested?
- Interleukin 6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2025to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo
Ahmed H Elsayed, M.B.B.CH, +201016305451, AhmedHanyAbdelfatah@med.asu.edu.eg
About this study
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.
Read the 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.
- Conditions
- Burns, Sepsis, Septic Shock, Death
- Being tested
- Interleukin 6
- Medical subject headings
- Burns, Sepsis, Shock, Septic, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin 6Diagnostic test
Also called Procalcitonin
Interleukin 6 and procalcitonin will be sampled for all patients on days 1, 3, 7, and 10
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Interleukin 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of sepsis and septic shock
Prediction of occurrence of sepsis and septic shock
Measured: From day 1 to day 10 in burn ICU
Secondary outcomes (1)
Length of ICU stay
Response to treatment and length of ICU stay for over one month
Measured: One month after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start10 Jan 2025
- Primary completion10 Jul 2025 (estimated)
- Study completion10 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed H Elsayed, M.B.B.CH, Principal investigator, Anaesthesia, intensive care, and pain management resident Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915974
- Sponsor's protocol ID
- FMASU MS 10/2024/2025
- Status last verified
- Jan 2025
- First submitted
- 14 Feb 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared once the study is completed
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Interleukin 6 and Procalcitonin in Detecting Sepsis and Incidence of Mortality in Burn ICU Patients
- ClinicalTrials.gov ID
- NCT06915974
- Acronym / sponsor ID
- FMASU MS 10/2024/2025
- Conditions
- Burns, Sepsis, Septic Shock, Death
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Jul 2025 (estimated)
- Study completion
- 10 Jul 2025 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Burn ICU patients | Experimental | Diagnostic Test: Interleukin 6Interleukin 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interleukin 6Also: ProcalcitoninInterleukin 6 and procalcitonin will be sampled for all patients on days 1, 3, 7, and 10 | Diagnostic test | Burn ICU patients |
Primary outcome
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
1 secondary outcome
Length of ICU stay
Time frame: One month after ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: Yes. All data will be shared once the study is completed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed H Elsayed, M.B.B.CH principal investigator
Anaesthesia, intensive care, and pain management resident Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interleukin 6 in people with Burns and Sepsis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed H Elsayed, M.B.B.CH (+201016305451, AhmedHanyAbdelfatah@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of sepsis and septic shock (time frame: From day 1 to day 10 in burn ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.