## Protocol Section
### Identification Module
**NCT ID:** NCT02549079

**Brief Title:** Soluble Factors in the Serum of Severely Burned Patients

**Official Title:** Soluble Factors in the Serum of Severely Burned Patients

#### Organization Study ID Info
**ID:** EK104/08
#### Organization
**Class:** OTHER
**Full Name:** RWTH Aachen University
### Status Module
#### Completion Date
**Date:** 2008-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-09-15

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-09-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-12

**Type:** ACTUAL

#### Start Date
**Date:** 2004-01

**Status Verified Date:** 2015-09

#### Study First Post Date
**Date:** 2015-09-14
**Type:** ESTIMATED
**Study First Submit Date:** 2015-09-11
**Study First Submit QC Date:** 2015-09-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** RWTH Aachen University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Burn Patients

### Design Module

#### Bio Spec

**Description:** blood samples

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 23

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Blood will be taken from all patients meeting the inclusion criteria.

**Name:** Blood sample

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Patients will be monitored over five days and death (with underlying condition, time) will be determined and documented by medical doctors.

**Measure:** Survival of a total of 23 burn patients during their treatment in the ICU

**Time Frame:** five days

#### Secondary Outcomes

**Description:** 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)

**Measure:** Onset of sepsis of a total of 23 burn patients during their treatment in the ICU

**Time Frame:** five days

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with burn injuries treated in the burn intensive care unit

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** RWTH Aachen University

**Name:** Norbert Pallua, M.D., Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5326

- Name: Burns

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
