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Completed

NCT Number: NCT02549079

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.

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Key information

Conditions

Burn Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

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

Primary outcomes

  1. Survival of a total of 23 burn patients during their treatment in the ICU

    Time frame: five days

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

Secondary outcomes

  1. Onset of sepsis of a total of 23 burn patients during their treatment in the ICU

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 14, 2015
Registry last updated
Sep 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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