Soluble Factors in the Serum of Severely Burned Patients

Completed

• Conditions: Burn Patients

• Registration Number: NCT02549079
• Lead Sponsor: RWTH Aachen University

Brief Summary

The present study investigates the levels of certain soluble factors in the blood of patients with severe burn injury. Serum levels of different soluble factors will be correlated with the clinical outcome, presence of sepsis, the area of burn, and other clinical parameters in order to make a statement regarding their use as biomarkers in the prediction and monitoring of burn patients.

Detailed Description

Burn patients still represent a critical patient collective with a high mortality rate although treatment technologies have improved over the years. One problem healthcare professionals face is the fact that reliable biomarker which predict the clinical outcome, the onset of sepsis, and monitor the severity of disease in burn patients are still missing. These biomarkers would allow an early adoption of treatment modalities to improve the outcome and prevent life-threatening complications.

Blood samples from severely burned patients will be collected over a period of five days and different cytokines (for example the macrophage migration inhibitory factor protein family) will be measured in the serum. Clinical data of the patients (sepsis, total body surface area of burns, abbreviated burn severity index, sepsis-related organ failure assessment, etc.) will be documented and correlated to the levels of soluble factors.

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2015-09
• Study First Submitted: 2015-09-11
• Study First Submitted QC: 2015-09-11
• Study First Posted: 2015-09-14
• Last Update Submitted: 2015-09-14
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• 18 years of age
• minimum of 10% total body surface area burn
• needing ICU treatment

Exclusion Criteria

• younger than 18 years of age
• immunosuppression (e.g. HIV)
• undergone surgery 2 weeks prior to burn injury
• malignancies
• severe diseases (myocardial infarction, lung embolism)
• declining to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival of a total of 23 burn patients during their treatment in the ICU	five days	Patients will be monitored over five days and death (with underlying condition, time) will be determined and documented by medical doctors.

Secondary Outcome Measures

Name	Time	Method
Onset of sepsis of a total of 23 burn patients during their treatment in the ICU	five days	Onset of systemic inflammatory response syndrome, sepsis, septic shock will be monitored by medical doctors by standardized assessment of clinical parameters according to the consensus of the American College of Chest Physicians (ACCP) and the Society of Critical Care Medicine (SCCM) (released in Critical Care Med, 20(6):864-74, 1992, Pubmed ID: 1597042)