Soluble Factors in the Serum of Severely Burned Patients

Burn Patients Clinical Trial

Official title:

Soluble Factors in the Serum of Severely Burned Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549079
• Other study ID #: EK104/08
• Status: Completed
• Phase: N/A
• First received: September 11, 2015
• Last updated: September 14, 2015
• Start date: January 2004
• Est. completion date: December 2008

Study information

• Verified date: September 2015
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bezirksregierung Köln, Dezernat 24
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Burn Patients

Intervention

Other:
• Blood sample
Blood will be taken from all patients meeting the inclusion criteria.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No