Genotypes and Phenotypes in Pediatric SIRS and Sepsis (GAPPSS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02728401|
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : April 19, 2018
|Condition or disease|
|Systemic Inflammatory Response Syndrome (SIRS) Sepsis|
The investigators will undertake a proof-of-concept, pilot, prospective, observational trial that aims to recruit ~90 children from the Seattle Children's Hospital Pediatric Intensive Care Unit (PICU) and Cardiac Intensive Care Unit (CICU). The study will plan to recruit 30 children who are scheduled for surgery to repair congenital cardiac malformations, 15 - 25 immunocompetent children with culture positive sepsis, and 15 - 25 immunocompromised children with culture positive sepsis, and 30-40 children who are polymerase chain reaction (PCR) positive for viral respiratory pathogens (RSV, influenza, parainfluenza, rhinovirus, etc), and who meet the eligibility criteria. In total, accounting for culture negative bacterial sepsis (estimated 40%), the investigators plan to enroll 50 children with sepsis, 30-40 with viral sepsis, and 20 children undergoing surgery for congenital heart disease.
Demographic data will be collected at the time of ICU admission. Illness severity will be quantified by PRISM III and day 1 PELOD scores. Additional measures of sepsis severity will include oxygenation index, saturation index and duration of mechanical ventilation, vasoactive inotropic score and duration of vasoactive-inotropic support and highest serum creatinine on day 1. Resource utilization will be measured as PICU and hospital duration of stay.
For all children enrolled in the study, blood samples will be obtained on study days 1, 2 and 3. For children with sepsis, if cultures remain sterile or PCR negative, no additional research blood samples will be obtained. For children with sepsis and a positive culture or positive PCR by study day 3, additional blood samples will be obtained on the day of PICU discharge.
|Study Type :||Observational|
|Actual Enrollment :||104 participants|
|Official Title:||Genotypes and Phenotypes in Pediatric SIRS and Sepsis (GAPPSS)|
|Actual Study Start Date :||May 1, 2013|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||December 31, 2017|
Infection-negative systemic inflammation (INSI). The INSI group consists of children who have undergone congenital cardiac defect corrective surgery requiring cardiopulmonary bypass, known to induce an INSI response for ~24 hours thereafter; all children in this cohort are culture negative. This group is demarcated further by inclusion & exclusion criteria (see Eligibility section below).
Clinical severe sepsis syndrome (CSSS). Children assigned to the CSSS group had confirmed or highly suspected infection (microbial culture orders, antimicrobial prescription), exhibited 2 or more systemic inflammatory response syndrome criteria (including temperature and leukocyte criteria), and demonstrated at least cardiovascular ± pulmonary organ dysfunction. This group is demarcated further by inclusion & exclusion criteria (see Eligibility section below).
The Viral Infection group consists of children who displayed signs and symptoms of severe viral infection, and who tested positive for respiratory viral infection(s) by a molecular virus panel test. These children were clinically evaluated to not have bacterial sepsis. This group is demarcated further by inclusion & exclusion criteria (see Eligibility section below).
- Gene Expression Levels [ Time Frame: Day 1 of admission to the pediatric intensive care unit (PICU) ]Gene expression levels (quantitative) will be compared between CSSS, INSI and viral infection groups, in a search for signatures that can discriminate these groups
- Serum Protein Expression Profiles [ Time Frame: Day 1 of admission to the pediatric intensive care unit (PICU) ]Serum protein expression profiles (semi-quantitative) will be compared between CSSS and INSI groups, in a search for signatures that can discriminate the two groups
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728401
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Jerry J Zimmerman, MD, PhD||Seattle Children's Hospital|