Trial document




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  DRKS00008177

Trial Description

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Title

Evaluation of biomarkers for neuronal cell injury in infants after surgery for congenital heart disease utilizing cardiopulmonary bypass - impact of cerebral tissue oxygenation.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In the last decades, Improvements in surgical techniques and in intraoperative and postoperative intensive care have led to a continuous decrease in mortality and morbidity after surgery for congenital heart disease in newborns and infants. Overall, Neurodevelopmental outcome is comparable to healthy children in the majority of patients who require repair of congenital heart defects in infancy. However, children with complex congenital heart disease often show deficits in certain cognitive domains such as motor and language development, visual perception and visual motor integration. Decreased oxygen saturations in the brain tissue after surgery utilizing cardiopulmonary bypass are discussed as a risk for impaired neurodevelopmental outcome. Tissue oxygenation in the brain can be measured non invasive with special light waves in the near infrared range. Using Near infrared spectroscopy (NIRS), a decline of cerebral tissue oxygenation within the early postoperative period after repair of congenital heart defects in infants has been observed in several previous studies. The underlying cause has not yet been identified. Lower cerebral tissue oxygen saturations have been associated with impaired neurodevelopmental outcome and with abnormalities in cerebral magnetic resonance imaging. The lower threshold of cerebral tissue oxygenation which may cause cerebral injury has not been defined.
For our study, we plan to measure preoperative, intraoperative and postoperative tissue oxygenation saturations for 48 hours with NIRS. In addition, so called "biomarkers" indicating neuronal cell damage will be measured in the blood. These biomarkers are certain components of neural cells, which will be released into the blood in case of cell damage. For our study we plan to evaluate two different biomarkers, S100B and glial fibrillary acid protein (GFAP), prior to surgery and at four different time points within the postoperative period. Neurodevelopmental outcome will be evaluated with the Bayley Scales of Infant Development" at an age of 24 to 36 months.

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Brief Summary in Scientific Language

In the last decades, improvements in surgical techniques and in intraoperative and postoperative intensive care have led to decrease in mortality and morbidity after surgery for congenital heart disease in newborns and infants. However, especially children with complex congenital heart disease, requiring surgery within the first days of life, often show deficits in neurocognitive development. But also children who underwent repair of less complex CHD during infancy, e.g. ventricular septal defects or Tetralogy of Fallot, may show deficits in certain cognitive domains such as motor and language development, visual perception and visual motor integration. Decreased oxygen saturations in the brain tissue after surgery utilizing cardiopulmonary bypass are discussed as a risk for impaired neurodevelopmental outcome. Tissue oxygenation in the brain can be continuously measured non-invasive with Near Infrared Spectroscopy (NIRS) and is used for perioperative monitoring in patients with CHD. A decline of cerebral tissue oxygenation within the early postoperative period after repair of congenital heart defects in infants has been observed in several previous studies. The underlying cause has not yet been identified. Lower cerebral tissue oxygen saturations have been associated with impaired neurodevelopmental outcome and with abnormalities in cerebral magnetic resonance imaging. Therefore, identification of modifiable risk factors and development of strategies to improve the long-term neurologic outcome are of special interest. In order to apply and evaluate these strategies, monitoring techniques and specific and sensitive markers for acute neurologic injury are needed.
The aim of the study is to evaluate to potential biomarkers for neuronal cell damage (S100B and glial fibrillary acid protein) together with preoperative, intraoperative and postoperative tissue oxygenation saturations. Relationships between biomarker levels, cerebral tissue oxygenation and neurodevelopmental outcome will be evaluated with the Bayley Scales of Infant Development.

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Organizational Data

  •   DRKS00008177
  •   2015/06/05
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  •   yes
  •   Approved
  •   A 150/14, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   Surgery for congenital heart defects utilizing cardiopulmonary bypass in newborns and infants.
  •   Q20-Q28 -  Congenital malformations of the circulatory system
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Interventions/Observational Groups

  •   Children with congenital heart disease undergoing surgery utilizing cardiopulmonary bypass within the first 12 months of life. Perioperative measurement of cerebral tissue Oxygen saturations and Evaluation of biomarkers for neural cell damage at five different time points (before surgery and 0, 12, 24 and 48 h after surgery). Evaluation of neurodevelopmental outcome with the Bayley Scales of Infant Development at 24-36 months of age.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Blinded
  •   assessor
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Maximum serum level of S100B and GFAP within the first 48 postoperative hours (blood draws at 0, 12, 24 and 48 hours after surgery) and perioperative cerebral tissue oxygenation obtained by NIRS. Evaluation of neurodevelopmental outcome at 24-36 months of age with Bayley-Scales of Infant Development.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/06/01
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   12   Months
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Additional Inclusion Criteria

Congenital heart defect, requiring surgical repair utilizing cardiopulmonary bypass within the first 12 months of life.

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Exclusion Criteria

Genetic syndrom associated with neurodevelopmental delay (proven or clinical suspicion), perinatal asphyxia, structural brain malformation, cerebral hemorrhage

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Addresses

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    • Klinik für angeborene Herzfehler und Kinderkardiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel
    • Mr.  Prof. Dr.  Hans-Heiner  Kramer 
    • Arnold-Heller-Strasse 3, Haus 9
    • 24105  Kiel
    • Germany
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    • Klinik für angeborene Herzfehler und Kinderkardiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel
    • Mr.  Dr. med.  Jan Hinnerk  Hansen 
    • Arnold-Heller-Strasse 3, Haus 9
    • 24105  Kiel
    • Germany
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    • Klinik für angeborene Herzfehler und Kinderkardiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel
    • Mr.  Dr. med.  Jan Hinnerk  Hansen 
    • Arnold-Heller-Strasse 3, Haus 9
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für angeborene Herzfehler und Kinderkardiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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