Septic ShockTAMOFNCT00118664
Patient Plasma Response and Outcome in Septic Shock With Thrombocytopenia Associated Multiple Organ Failure in Children
An observational study of Septic Shock and Thrombocytopenia, run by Children's Healthcare of Atlanta at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Septic Shock, Thrombocytopenia, Multiple Organ Failure
- How many people
- 86 participants
- Where
- 12 sitesUnited States
- Study dates
- May 2005to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients admitted to a participating PICU.
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Michigan Medical Center, Mott Children's Hospital
Ann Arbor, Michigan, 48109-0243
Children's Healthcare of Atlanta at Egleston and Scottish Rite
Atlanta, Georgia, 30322
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Columbus Childrens Hospital
Columbus, Ohio, 43205
Cook Children's Hospital
Fort Worth, Texas, 76104
Texas Children's Hospital
Houston, Texas, 77030
University of Iowa Children's Hospital
Iowa City, Iowa, 52242
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
LSU Health Sciences Center
Shreveport, Louisiana, 71130
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About 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.
Read the 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.
- Conditions
- Septic Shock, Thrombocytopenia, Multiple Organ Failure
- Keywords
- Septic Shock, Thrombocytopenia, Multiple Organ Failure, Pediatric
- Medical subject headings
- Shock, Septic, Thrombocytopenia, Multiple Organ Failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2005 (estimated)
- Study startMay 2005
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James D. Fortenberry, MD, Principal investigator, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118664
- Sponsor's protocol ID
- 05-004
- Acronym
- TAMOF
- Status last verified
- Jun 2016
- First submitted
- 1 Jul 2005
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Plasma Response and Outcome in Septic Shock With Thrombocytopenia Associated Multiple Organ Failure in Children
- ClinicalTrials.gov ID
- NCT00118664
- Acronym / sponsor ID
- TAMOF / 05-004
- Conditions
- Septic Shock, Thrombocytopenia, Multiple Organ Failure
- Keywords
- Septic Shock, Thrombocytopenia, Multiple Organ Failure, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 12 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients admitted to a participating PICU.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James D. Fortenberry, MD principal investigator
Children's Healthcare of Atlanta
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Thrombocytopenia, run by Children's Healthcare of Atlanta at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2016.