ICIS in Burn Patients Compared to Other Inflammatory Markers

NCT04894500 | Completed

• 1 other identifier: 0402021
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

The current markers of inflammation that govern antibiotic treatment have their significant limitations, especially in patients with burns. According to previously published data, the newly proposed marker of infectious inflammation, the Intensive Care Infection Score (ICIS), appears to be a suitable diagnostic tool in distinguishing between inflammation of infectious and non-infectious origin in these patients. The other advantage is its low price. This study aims to compare ICIS with other used indicators of inflammation in patients with burns both children and adults.

Conditions

Burns; Infection, Bacterial; Inflammation

Outcome Measures

Primary Outcomes (1)

• The Intensive Care Infection Score is not inferior to selected inflammatory markers in detection of bacterial infection

  Comparison of the ICIS to CRP, PCT, IL-6, WBC, TNF-α, and Presepsin

  15 days

Secondary Outcomes (3)

• The Intensive Care Infection Score is a suitable biomarker for distinguishing bacterial infection from systemic inflammatory response syndrome (SIRS)

  30 days

• The Intensive Care Infection Score does not depend on the extend and depth of the burn area

  5 days

• The Intensive Care Infection Score is a suitable marker of bacterial infection in children with burns

  10 days

Interventions

Flow fluorescence cytometry DIAGNOSTIC_TEST

Level of inflammatory markers in body fluid samples

Also known as: CRP, PCT, Presepsin, IL-6, TNF-α, WBC

Eligibility Criteria

• Age: 6 Months - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted for burn injuries.

You may qualify if:

• All patients hospitalized on Prague Burn Centre, Czech Republic, for more than 3 days.

You may not qualify if:

• Refusal to sign informed consent or withdrawal of already signed consent;
• Patient in palliative care.

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

Location

Related Publications (3)

• van der Geest PJ, Mohseni M, Linssen J, Duran S, de Jonge R, Groeneveld AB. The intensive care infection score - a novel marker for the prediction of infection and its severity. Crit Care. 2016 Jul 7;20(1):180. doi: 10.1186/s13054-016-1366-6.

  PMID: 27384242 BACKGROUND

• Nierhaus A, Linssen J, Wichmann D, Braune S, Kluge S. Use of a weighted, automated analysis of the differential blood count to differentiate sepsis from non-infectious systemic inflammation: the intensive care infection score (ICIS). Inflamm Allergy Drug Targets. 2012 Apr;11(2):109-15. doi: 10.2174/187152812800392841.

  PMID: 22280231 BACKGROUND

• Weimann K, Zimmermann M, Spies CD, Wernecke KD, Vicherek O, Nachtigall I, Tafelski S, Weimann A. Intensive Care Infection Score--A new approach to distinguish between infectious and noninfectious processes in intensive care and medicosurgical patients. J Int Med Res. 2015 Jun;43(3):435-51. doi: 10.1177/0300060514557711. Epub 2015 Apr 7.

  PMID: 25850686 BACKGROUND

MeSH Terms

Conditions

Bacterial Infections; Burns; Inflammation

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Helena Lahoda Brodská, MD, PhD

  Ústav lékařské biochemie a laboratorní diagnostiky 1. LF UK a Všeobecné fakultní nemocnice Praha

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intensive Care lead

Study Record Dates

• First Submitted: May 16, 2021
• First Posted: May 20, 2021
• Study Start: April 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: October 31, 2024
• Last Updated: January 7, 2026

Record last verified: 2023-08

Locations

CZ (1)