Patient Plasma Response and Outcome in Septic Shock With Thrombocytopenia Associated Multiple Organ Failure in Children
Condition: Septic Shock; Thrombocytopenia; Multiple Organ Failure
MeSH terms: Shock, Septic; Thrombocytopenia; Shock; Multiple Organ Failure
Study type: Observational

Summary: 
      The purpose of this study is to learn how blood clotting substances respond in children with
      septic shock, low platelet counts, and multiple organ failure (MOF) treated at different
      institutions.

      Multiple organ failure can be related to an infection producing "septic shock," in which
      substances released in the blood cause poor blood flow to the organs. The number of platelets
      circulating in your child's blood stream is also decreased (this is called
      "thrombocytopenia") as a result of this condition. Research has shown that certain substances
      in the part of the blood known as plasma (the clear liquid part of the blood not including
      the red blood cells but holding blood clotting factors) can cause the organs to work poorly.
      The investigators would like to compare these blood responses in children with this
      condition, receiving a variety of different treatments, for multiple organ failure in other
      medical centers around the world. The investigators hope to enroll 80 patients into the
      study.
    

Detailed description: 
      Researchers have defined a subgroup of pediatric patients with critical illness who have a
      specific coagulation profile associated with thrombocytopenia. This distinct entity, defined
      as thrombocytopenia-associated multiple organ failure (TAMOF), has been demonstrated to
      predispose affected children to worsening organ failure and increased risk of death. A
      preliminary single-center study performed at Children's Hospital of Pittsburgh (CHP)
      suggested significant improvement in organ system dysfunction in TAMOF patients using a
      plasma exchange protocol compared to standard therapy alone. The investigators desire to
      further evaluate plasma profiles and clinical outcomes in pediatric TAMOF in a broader
      geographic setting. The investigators propose to perform a prospective multi-center
      observational cohort study to evaluate plasma response and clinical outcomes in pediatric
      patients with TAMOF due to critical illness associated with systemic infection, sepsis, organ
      transplant, chemotherapy or cardiopulmonary bypass. Plasma samples will be obtained from all
      patients for measurement of markers of coagulation and inflammation. The primary clinical
      endpoints measured will be organ failure index scores, pediatric logistic organ dysfunction
      (PELOD) scores, and days until resolution of organ failures. Cohort outcome analysis will
      also be performed by pairing patients at different centers receiving standard therapy with
      those receiving plasma exchange as an additional therapy.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients admitted to a participating PICU.
      
Keywords: Septic Shock; Thrombocytopenia; Multiple Organ Failure; Pediatric