Patient Plasma Response and Outcome in Septic Shock With Thrombocytopenia Associated Multiple Organ Failure in Children

Completed

Conditions studied: Septic Shock, Thrombocytopenia, Multiple Organ Failure

In brief

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.

Key facts

Study ID

NCT00118664

Run by

Children's Healthcare of Atlanta

People needed

86

Starts

2005-05-01

Expected to finish

2012-02-01

Last updated by the study team

2016-06-14

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.)

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Children's Healthcare of Atlanta at Egleston and Scottish Rite — Atlanta, Georgia, United States
• University of Iowa Children's Hospital — Iowa City, Iowa, United States
• LSU Health Sciences Center — Shreveport, Louisiana, United States
• University of Michigan Medical Center, Mott Children's Hospital — Ann Arbor, Michigan, United States
• Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Columbus Childrens Hospital — Columbus, Ohio, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt Children's Hospital — Nashville, Tennessee, United States
• Cook Children's Hospital — Fort Worth, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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