Soluble Factors in the Serum of Severely Burned Patients

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.

Study Overview

• Status: Completed
• Conditions: Burn Patients
• Intervention / Treatment: Other: Blood sample

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 Type: Observational
• Enrollment (Actual): 23

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with burn injuries treated in the burn intensive care unit

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of sepsis of a total of 23 burn patients during their treatment in the ICU	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)	five days

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Norbert Pallua, M.D., Ph.D., RWTH Aachen University

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: September 11, 2015
• First Submitted That Met QC Criteria: September 11, 2015
• First Posted (Estimate): September 14, 2015

Study Record Updates

• Last Update Posted (Estimate): September 15, 2015
• Last Update Submitted That Met QC Criteria: September 14, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: EK104/08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No