Septic Shock | Patient Plasma Response and Outcome in Septic Shock With Thrombocytopenia Associated Multiple Organ Failure in Children
Septic Shock research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: All pediatric Intensive Care Unit (ICU) patients with the following inclusion criteria are eligible for enrollment: - Weight > 5 kilograms (minimum weight required due to technical limits of exchange equipment) - Multiple organ failure, defined as organ failure index (OFI) score > 3 present for < 30 hours - Patients must have new (not present prior to admission) organ failure in at least 3 of the 5 organ systems. - Thrombocytopenia (platelet count < 100,000 per ul), or in patients with a baseline platelet count < 100,000 per ul, a minimum 50% decrease in platelet count - Etiology of MOF due to systemic infection, shock, transplantation, chemotherapy, or cardiopulmonary bypass Exclusion Criteria: - Treatment prior to study entry with any form of plasma exchange therapy within 30 days not for TAMOF - Thrombocytopenia secondary to diagnosed thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS) - Patients with terminal illness (i.e. not expected to live > 60 days even if they survive this acute illness) or in which withdrawal of therapy is being considered (do-not-resuscitate [DNR]/comfort measures only, limited therapy etc.)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Multiple Organ Failure
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: May 2005
Completed Date: February 2012
Study sponsors, principal investigator, and references
Principal Investigator: James D. Fortenberry, MD
Lead Sponsor: Children's Healthcare of Atlanta