Genotypes and Phenotypes in Pediatric SIRS and Sepsis



Status:Completed
Conditions:Infectious Disease, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:Any - 18
Updated:4/21/2018
Start Date:May 1, 2013
End Date:December 31, 2017

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Genotypes and Phenotypes in Pediatric SIRS and Sepsis (GAPPSS)

The aim of this investigation is to longitudinally quantify host gene expression and serum
proteins in children with infectious and non-infectious SIRS. The investigators hypothesize
that children with non-infectious SIRS, with bacterial infection associated SIRS, or with
viral infection associated SIRS will exhibit distinct patterns of host gene expression and
serum proteins. The investigators further hypothesize that it should be possible to discover
sets of mRNA or protein biomarkers that will permit unambiguous diagnosis of non-infectious
SIRS, SIRS associated with bacterial infection, and SIRS associated with viral infection.

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.

A. INSI group: systemic inflammation, in the absence of culture positive infection. Cardiac
surgery patients, n=30.

Inclusion Criteria:

- Admission to the CICU AND

- Age ~1-18 years AND

- Weight exceeding 10 kg

- Vascular catheter capable of providing the blood draw or anticipated orders for
venipuncture for clinical labs AND

- Status post open heart surgery requiring cardiopulmonary bypass AND

- Parents speak English AND

- Not previously enrolled in the GAPPSS investigation

Exclusion Criteria:

- Pre- or post-operative culture positive infection OR

- Not expected to survive the CICU stay OR

- Ward of the state OR

- Concurrent malignancy or autoimmune disorder

B. CSSS (Clinical Severe Sepsis Syndrome) group: systemic inflammation, in the presence of
highly suspected or documented bacterial infection. Children with clinical severe sepsis, n
= 40. In this group, the investigators will enroll children who are immunocompetent as well
as children who are immunocompromised.

Inclusion Criteria:

- Admitted to the PICU AND

- Age newborn (>38 weeks EGA)-18 years AND

- Weight equal to or greater than 4 kg AND

- Vascular catheter capable of providing the blood draw or anticipated orders for
venipuncture for clinical labs AND

- At least one organ dysfunction (severe sepsis) AND

- Parents speak English AND

- SIRS (systemic inflammatory response syndrome) AND

- Strongly suspected or documented source of infection

- Not previously enrolled in the GAPPSS investigation

Exclusion Criteria:

- PICU nosocomial primary infection accounting for the sepsis event

- Not expected to survive the PICU stay

- Ward of the state

C. Viral Infection group. Severe respiratory dysfunction in the presence of PCR -documented
viral infection. Children with clinical severe viral sepsis, n=6. In this group, the
investigators will enroll children who are immunocompetent as well as children who are
immunocompromised.

Inclusion Criteria:

- Admitted to the PICU AND

- Age newborn (>38 weeks EGA)-18 years AND

- Weight equal to or greater than 4 kg AND

- Vascular catheter capable of providing the blood draw or anticipated orders for
venipuncture for clinical labs AND

- Parents speak English AND

- Severe respiratory dysfunction requiring invasive or non-invasive positive pressure
mechanical ventilation support AND

- Positive PCR verifying a viral infection

- Not previously enrolled in the GAPPSS investigation

Exclusion Criteria:

- PICU nosocomial primary infection accounting for the sepsis event

- Not expected to survive the PICU stay

- Ward of the state
We found this trial at
1
site
4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
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