Trial document




drksid header

  DRKS00009686

Trial Description

start of 1:1-Block title

Title

Capillary Leak in Burn Patients

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

CLIB

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Patients with extensive burns suffer from a leaking vascular system during the first hours after the trauma. Blood fluids leak into soft tissues and organs and form edema. Both, the vessel leakage and the edema formation lead to an undersupply of organs of the human body with blood. Thus the body of the patients gets further damaged due to the malfunction of the vascular barrier that is not directly caused by the burn trauma.

10 patients suffering a severe burn of at least 20% of their body surface area will be included in the study.

Repeated blood and urine analyzes will be performed to detect breakdown products of the vessel wall. Through ultrasound examinations of the soft tissues, the extent of edema formation shall be measured.

The hypothesis of the study is that on the basis of the breakdown products of the vessel walls in the blood and the urine conclusions can be drawn about the nature and the temporal course of the vascular wall lesions.

Through a better understanding of the mechanisms leading to vascular leakage and edema formation, strategies shall be developed to protect burn patients from serious complications.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Patients with extensive burns suffer from a leaking vascular system during the first hours after the trauma. Blood fluids leak into soft tissues and organs and form edema. Pulmonary edema, brain edema and abdominal compartment syndrome are particular complications that worsen the outcome of the patients. Both, the vessel leakage and the edema formation lead to an undersupply of organs of the human body with blood. Thus the body of the patients gets further damaged due to the malfunction of the vascular barrier that is not directly caused by the burn trauma. The mechanisms that cause damage of the vascular barrier are not well understood. However breakdown of the endothelial glycocalyx and of the endothelial basal membrane seem to be causative.

10 patients suffering a severe burn of at least 20% of their body surface area will be included in the study.

Repeated blood and urine analyzes will be performed to detect breakdown products of the vessel wall (syndecan-1, glycosaminoglycane, endostatin, cathepsin-L, tumstatin, matrix-metalloprotease 2, matrix-metalloprotease 9). Aditionally blood NTpor-BNP and TNF-alpha will be evaluated due to their potential to initiate glycocalyx breakdown.Through ultrasound examinations of the soft tissues, the extent of edema formation shall be measured.

The hypothesis of the study is that on the basis of the breakdown products of the vessel walls in the blood and the urine conclusions can be drawn about the nature and the temporal course of the vascular wall lesions.

Through a better understanding of the mechanisms leading to vascular leakage and edema formation, strategies shall be developed to protect burn patients from serious complications.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00009686
  •   2015/11/20
  •   [---]*
  •   yes
  •   Approved
  •   119/2014, Ethik-Kommission der Universität Witten/Herdecke
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   T29.0 -  Burns of multiple regions, unspecified degree
  •   T79 -  Certain early complications of trauma, not elsewhere classified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with a burn trauma of equal to / greater than 20 % of their body surface will be observed.
    Evaluation of biochemical variables will be performed: blood fragments of the vascular barrier, proteinuria.
    Further measurements: Edema quantification by tissue ultrasound.
    Time points of observation will be : admission to the burn intensive care unit and after 6 h , 12 h , 24 h , 48 h , 96 h , 192 h .
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Primary outcome variables are variables defining microcirculatory failure: 1. endothelial dysfunction, 2. capillary leak, 3. proteinuria.
The observation period of the study will be 196 h from patient admission. All variables, defined under points 1 - 3, will be measured at the following time points during the study: at admission on the intensive care unit and after 6, 12, 24, 48, 96 and 192 hours after admission.
1. defined by blood concentrations of syndecan-1, glycosaminoglycans, endostatin, cathepepsin-L, tumstatin, matrix-metalloproteinase 2, matrix-metalloproteinase 9
2. defined by tissue ultrasound meausrements based on the concept of Suehiro et al. (Annals of vascular diseases. 2013:6(2):180-8)
3. content of total proteins in 24h urine collection

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Secondary endpoints:
- Pulmonary edema found in chest x-ray
- Intra-abdominal pressure
- Body weight
- Cumulative Fluid balance
- Blood NTpro-BNP
- Blood TNF-alpha

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2017/11/01
  •   10
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- burn injury equal / larger than 20% of body surface area

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Patient suffered burn trauma longer than 24 h ago
- Further traumata in the sense of polytrauma
- Any other condition deemed unsuitable by the Medical Director for study inclusion
- Refusal of inclusion by the patient, his legal guardian or the consultant in charge of the initial inclusion

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Private Universität Witten/Herdecke gGmbH
    • Alfred-Herrhausen-Straße 50
    • 58448  Witten
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universität Witten/Herdecke Lehrstuhl für Anästhesiologie II und Deutsches Zentrum für Luft- und Raumfahrt, Institut für Luft und Raumfahrtmedizin
    • Mr.  Dr. med.  Ulrich  Limper 
    • Linder Höhe 1
    • 51147  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universität Witten/Herdecke Lehrstuhl für Anästhesiologie II und Deutsches Zentrum für Luft- und Raumfahrt, Institut für Luft und Raumfahrtmedizin
    • Mr.  Dr. med.  Ulrich  Limper 
    • Linder Höhe
    • 51147  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Private Universität Witten/Herdecke gGmbH
    • Alfred-Herrhausen-Straße 50
    • 58448  Witten
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Deutsches Zentrum für Luft- und RaumfahrtInstitut für Luft- und RaumfahrtmedizinAbteilung Weltraumphysiologie
    • Linder Höhe
    • 51147  Köln
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.