Trial document





This trial has been registered retrospectively.
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  DRKS00003546

Trial Description

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Title

Microdialysis for monitoring inflammation in newborn and infants operated on cardiopulmonary bypass for congenital heart surgery.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of our study is to establish microdialyis (MD) as a minimally invasive technique to explore concentration rate of body´s own mediators, like inflammatory markers, in routine clinical practice. It is well known that heart surgery with cardiopulmonary bypass (CPB) is associated with prolonged inflammation. The extent of systemic inflammatory response depends on the technique and used parts of CPB. MD enables to examine the interstitial space of adipose tissue. To collect samples it is necessary to place a MD catheter into one lateral thigh subcutaneously. This catheter consists of an inner tube and an outer tube with semipermeable membrane. The diameter is 0.6 mm. Isotonic perfusion fluid is pumped into the catheter entering the space between the outer and inner concentric tube. Exchange of substances take place on the semipermeable membrane at the distal end of the MD catheter. Our samples will be collected during surgery for subsequent analysis. The catheter will be removed on ICU not later than 24 hrs after insertion of the MD catheter.

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Brief Summary in Scientific Language

1. Microdialysis (MD) is a minimally invasive technique which enables monitoring inflammation. For a short time microdialysis catheter CMA 71 with high-cutoff membrane enables to sample and analyse cytokines and other inflammatory macromolecules in adipose tissue. The major problem of corrective heart surgery with cardiopulmonary bypass (CPB), especially in newborns and infants, is prolonged systemic inflammation leading to capillary leak syndrome (CLS). The extant of CLS could vary from slight oedema and fever to circulatory affected hypovolaemia with renal failure and shock. The extent of systemic inflammatory response depends on the technique and used parts of CPB.
2. The aim of this study is to measure local inflammatory markers in adipose tissue with the aid of CMA 71 catheter. The target group of our study are newborns and infants in the first year of life. These children remain a high-risk group after corrective heart surgery with CPB, regarding developing CLS as in older children. The MD catheter will be inserted after anaesthesia to avoid secondary stress. We want to start with measuring at the beginning of surgery and end not later than 24 hrs after insertion of the MD catheter. Actually there are only few experience with the new CMA 71 catheter (off label use).
With this study we want to optimise CPB technique to anticipate and prevent CLS.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003546
  •   2012/11/09
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  •   yes
  •   Approved
  •   192/09, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   congenital heart disease, capillary leak
  •   Q20-Q28 -  Congenital malformations of the circulatory system
  •   I78.8 -  Other diseases of capillaries
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Interventions/Observational Groups

  •   After anesthesia the microdailysis catheter will be placed on lateral thigh. Then we want to detect the local inflammatory response. Finally we want to compare the inflammatory profile in patients who develop CLS with those patients without CLS.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Our study should give an answer to question, if it is possible to monitor the extant of inflammatory response to cardiac surgery entailing cardiopulmonary bypass.

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Secondary Outcome

If we get feasible data about the postoperative inflammatory response with the aid of microdialysis we want to use microdialysis as a monitoring tool to optimise cardiopulmonary bypass technique.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2009/08/11
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   1   Days
  •   365   Days
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Additional Inclusion Criteria

Newborns and infants within the first year of life who underwent cardiac surgery with cardiopulmonary bypass.

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Exclusion Criteria

Children with infection prior to surgery

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Addresses

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    • Zentrum für Kinder- und Jugendmedizin des Universitätsklinikums Freiburg Klinik III: Angeborene Herzfehler / Pädiatrische Kardiologie
    • Mr.  Dr. med.  Jochen  Grohmann 
    • Mathildenstraße 1
    • 79106  Freiburg
    • Germany
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    • Zentrum für Kinder- und Jugendmedizin des Universitätsklinikums Freiburg Klinik III: Angeborene Herzfehler / Pädiatrische Kardiologie
    • Mr.  Dr. med.  Jochen   Grohmann 
    • Mathildenstraße 1
    • 79106  Freiburg
    • Germany
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    • Zentrum für Kinder- und Jugendmedizin des Universitätsklinikums Freiburg Klinik III: Angeborene Herzfehler / Pädiatrische Kardiologie
    • Mr.  Dr. med.  Jochen  Grohmann 
    • Mathildenstraße 1
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Zentrum für Kinder- und Jugendmedizin des Universitätsklinikums Freiburg Klinik III: Angeborene Herzfehler / Pädiatrische Kardiologie
    • Ms.  Prof. Dr. med.  Brigitte  Stiller 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2009/10/19
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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.