Genotypes and Phenotypes in Pediatric SIRS and Sepsis

Completed

Conditions studied: Systemic Inflammatory Response Syndrome (SIRS), Sepsis

In brief

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.

Key facts

Study ID

NCT02728401

Run by

Seattle Children's Hospital

People needed

104

Starts

2013-05-01

Expected to finish

2017-12-31

Last updated by the study team

2018-04-19

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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