NCT02549079

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

4.9 years

First QC Date

September 11, 2015

Last Update Submit

September 14, 2015

Conditions

Burn Patients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    five days

Interventions

Blood sampleOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with burn injuries treated in the burn intensive care unit

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Norbert Pallua, M.D., Ph.D.

    RWTH Aachen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2015

First Posted

September 14, 2015

Study Start

January 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

September 15, 2015

Record last verified: 2015-09