Patient Plasma Response and Outcome in Septic Shock With Thrombocytopenia Associated Multiple Organ Failure in Children (TAMOF)
Recruitment status was Recruiting
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Purpose
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.
| Condition |
|---|
|
Septic Shock Thrombocytopenia Multiple Organ Failure |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Patient Plasma Response and Outcome in Septic Shock With Thrombocytopenia Associated Multiple Organ Failure in Children |
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2005 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 6 Months to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Pediatric patients admitted to a participating PICU.
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.)
Contacts and Locations| Contact: Kristine M Rogers, RN | 404-785-1215 | kristine.rogers@choa.org |
| Contact: James D Fortenberry, MD | 404-785-1600 | james.fortenberry@choa.org |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Karen B Woronick, RN 202-476-5586 KWoronic@cnmc.org | |
| Principal Investigator: Heidi Dalton, MD | |
| United States, Georgia | |
| Children's Healthcare of Atlanta at Egleston and Scottish Rite | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Kristine M Rogers, RN 404-785-1215 kristine.rogers@choa.org | |
| Contact: James D Fortenberry, MD 404-785-1600 james.fortenberry@choa.org | |
| Principal Investigator: James D Fortenberry, MD | |
| Sub-Investigator: Munir Kapasi, MD | |
| United States, Iowa | |
| University of Iowa Children's Hospital | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Courtney Harkness 319-356-3988 Courtney-Harkness@uiowa.edu | |
| Principal Investigator: Patrick Brophy, MD | |
| United States, Louisiana | |
| LSU Health Sciences Center | Recruiting |
| Shreveport, Louisiana, United States, 71130 | |
| Contact: Keith Scott, MD lscott2@lsuhsc.edu | |
| Principal Investigator: L. Keith Scott, MD | |
| United States, Michigan | |
| University of Michigan Medical Center, Mott Children's Hospital | Recruiting |
| Ann Arbor, Michigan, United States, 48109-0243 | |
| Contact: Monica S Weber, RN 734-763-7131 monij@med.umich.edu | |
| Principal Investigator: Yong Y Han, MD | |
| United States, Minnesota | |
| Children's Hospitals and Clinics of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55404 | |
| Contact: Rod Tarrago, MD 612-863-3226 rod.tarrago@childrenshc.org | |
| Principal Investigator: Rod Tarrago, MD | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Marie Monaco, RN 513-636-5572 marie.monaco@cchmc.org | |
| Principal Investigator: Derek S Wheeler, MD | |
| Columbus Childrens Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Mark W Hall, MD 614-722-3436 hallma@pediatrics.ohio-state.edu | |
| Principal Investigator: Mark Hall, MD | |
| United States, Pennsylvania | |
| Children's Hospital of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Rajesh Aneja, MD 412-692-7366 anejrx@ccm.upmc.edu | |
| Principal Investigator: Rajesh Aneja, MD | |
| Sub-Investigator: Joseph Carcillo, MD | |
| United States, Tennessee | |
| Vanderbilt Children's Hospital | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Theresa M. Shalaby, RN, BSN 615-936-1819 theresa.shalaby@vanderbilt.edu | |
| Principal Investigator: Venkat Shankar, MD | |
| United States, Texas | |
| Cook Children's Hospital | Recruiting |
| Fort Worth, Texas, United States, 76104 | |
| Contact: Leigh Donahue, RN, MBA 682-885-6722 leighd@cookchildrens.org | |
| Principal Investigator: James D Marshall, MD | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Will May 832-826-6281 | |
| Principal Investigator: Trung Nguyen, MD | |
| Principal Investigator: | James D. Fortenberry, MD | Children's Healthcare of Atlanta |
More Information
No publications provided
| Responsible Party: | Children's Healthcare of Atlanta |
| ClinicalTrials.gov Identifier: | NCT00118664 History of Changes |
| Other Study ID Numbers: | 05-004 |
| Study First Received: | July 1, 2005 |
| Last Updated: | March 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Healthcare of Atlanta:
|
Septic Shock Thrombocytopenia Multiple Organ Failure Pediatric |
Additional relevant MeSH terms:
|
Thrombocytopenia Multiple Organ Failure Shock Shock, Septic Pathologic Processes Sepsis |
Infection Systemic Inflammatory Response Syndrome Inflammation Blood Platelet Disorders Hematologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013