Trial document




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  DRKS00008317

Trial Description

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Title

carbonyl-stress as a mediator in the acute respiratory distress syndrome-trial (ARDS)

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Trial Acronym

CASTRA-Trial

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Acute respiratory distress syndrome (ARDS), previously known as respiratory distress syndrome (RDS), acute lung injury, adult respiratory distress syndrome, or shock lung, is a severe, life-threatening medical condition characterized by widespread inflammation in the lungs. While ARDS may be triggered by a trauma or lung infection, it is usually the result of sepsis. The predisposing factors of ARDS are numerous and varied. Common causes of ARDS include sepsis, pneumonia, trauma, multiple blood transfusions, babesiosis, lung contusion, aspiration of stomach contents, and drug abuse or overdose. Other causes of ARDS include burns, pancreatitis, near drowning, or the inhalation of chemical irritants such as smoke, phosgene, or chlorine gas. The syndrome has a high mortality between 20 and 50%. The mortality rate with ARDS varies widely based on disease severity, a person's age, and the presence of other medical conditions. [1,2]Within the scope of this study the following parameters will be measured of 30 patients with severe ARDS at the time points onset, 5d and 10d: general laboratory parameters (e.g. number of leukocytes, CRP, PCT etc.), hemodynamics, breathing, blood gas, metabolics, balance and evaluation of the severity of disease by daily calculation of APACHE II-, SOFA-, SAPS- und DIC-Scores. Additionally a BAL will be carried out to extract bronchial secretion, to check for metabolites of carbonyl stress and analysing the bronchial microbiom. The same procedure will carrid out in lunghealthy pateints undergoing an operation at one timepoint.
1.) ARDS Definition Task Force, Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition.JAMA. 2012 Jun 20;307(23):2526-33.
2.) Brun-Buisson C, Minelli C, Bertolini G, Brazzi L, Pimentel J, Lewandowski K, Bion J, Romand JA, Villar J, Thorsteinsson A, Damas P, Armaganidis A, Lemaire F; ALIVE Study Group. Epidemiology and outcome of acute lung injury in European intensive care units. Intensive Care Med 2004; 30:4-6.

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Brief Summary in Scientific Language

Within the scope of this study the following parameters will be measured of 30 patients with severe ARDS at the time points onset, 5d and 10d: inflammatory markers (e.g. IL-6, TNF-alpha, TAC), general laboratory parameters (e.g. number of leukocytes, CRP, PCT etc.), MG as an important carbonylstress parameter, hemodynamics, breathing, blood gas, metabolics, balance and evaluation of the severity of disease by daily calculation of APACHE II-, SOFA-, SAPS- und DIC-Scores. Additionally a BAL will be carried out to extract bronchial secretion, to check for metabolites of carbonyl stress and analysing the bronchial microbiom. The same procedure will carrid out in 30 lunghealthy patients undergoing an Operation timepoint. In the group of lunghealthy patients we only perform the measurement at one timepoint, at the beginng of the operation.

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Organizational Data

  •   DRKS00008317
  •   2015/10/28
  •   [---]*
  •   yes
  •   Approved
  •   S-063/2015, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   J80 -  Adult respiratory distress syndrome
  •   A41 -  Other sepsis
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Interventions/Observational Groups

  •   Within the scope of this study the following parameters will be measured of 30 patients with severe ARDS at the time points onset, 5d and 10d: general laboratory parameters (e.g. number of leukocytes, CRP, PCT etc.), Screening marker for inflammtory an oxidative stress (e.g. IL-6, TNF-Alpha, TAC), hemodynamics, breathing, blood gas, metabolics, balance and evaluation of the severity of disease by daily calculation of APACHE II-, SOFA-, SAPS- und DIC-Scores. Additionally a BAL will be carried out to extract bronchial secretion, to check for metabolites of carbonyl stress and analysing the bronchial microbiom (via RNA-analysis).
  •   Within the scope of this study the following parameters will be measured of 30 lunghelthy patients at one time point: general laboratory parameters (e.g. number of leukocytes, CRP, PCT etc.), Screening marker for inflammtory an oxidative stress (e.g. IL-6, TNF-Alpha, TAC), hemodynamics, breathing, blood gas, metabolics, balance and evaluation of the severity of disease by daily calculation of APACHE II-, SOFA-, SAPS- und DIC-Scores. Additionally a BAL will be carried out to extract bronchial secretion, to check for metabolites of carbonyl stress and analysing the bronchial microbiom (via RNA-analysis).
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Prognosis
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

*Detection of the inflammatory induced cytocine-production, as well as the oxidative- and carbonyl-stress in Plasma and BAL samples of ARDS patients at the timepoints: onset, 5d and 10d.

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Secondary Outcome

*Evaluation of the individual patients outcome according to the MG-concentration in plasma and BAL samples of ARDS patients at the timepoints: onset, 5d and 10d.
*Pulmonary microbiome analyse and its changes during the therapy at the timepoints(BAL): onset, 5d and 10d.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2015/11/01
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Patients with severe ARDS:
*Written consent form of study participant or his appointed representative
*Age > 18 years
*ARDS-criteria have to be fulfilled (Berlin definition 2012)
Healthy-probands:
*Written consent form of study participant or his appointed representative
*Age > 18 years
*no acute or chronical inflammatory disease

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Exclusion Criteria

*Non-fulfillment of inclusion criteria
*Chronic inflammatory disease
*immune suppressive therapy
*pregnancy
*HIV positive patients
*Refusal of participation in the study

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum HeidelbergKlinik für Anästhesiologie
    • Mr.  Dr. med.  Felix Carl Fabian  Schmitt 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum HeidelbergKlinik für Anästhesiologie
    • Mr.  Dr. med.  Felix Carl Fabian  Schmitt 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.