An observational study in Sepsis, sponsored by Universitätsklinikum Hamburg-Eppendorf. Status unknown at 2 sites in Germany. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2017-06-23.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational
This study is designed to assess the role of neutrophil extracellular traps (NETs) in neonatal and pediatric sepsis as well as to evaluate markers of NETs formation as early predictors of neonatal and pediatric sepsis.
Severe infection resulting in sepsis is recognized as a leading cause of morbidity and mortality worldwide (Stehr and Reinhart, 2013). The incidence of sepsis in developed nations has been increasing while overall mortality is decreasing, but still remains around 30% (Mayr et al., 2014). Moreover, morbidity in survivors is often functionally devastating, and may include neurological impairment, chronic organ dysfunction, increased days admitted to hospital, and high rates of mortality postdischarge (Prescott et al., 2014). Emotional, social, and financial costs to individuals and health care systems are immense (Brun-Buisson et al., 2003).
Neutrophils are the first line of innate immune defense against infectious agents. In addition, neutrophils' ability to eliminate pathogens by phagocytosis and/or degranulation, it has recently been demonstrated that neutrophils can bind to and kill a wide range of microorganisms by forming neutrophil extracellular traps (NETs) (Brinkmann et al., 2004). This novel mechanism consists of the release of web-like structures of DNA decorated with histones and antimicrobial proteins, known as NETs. Microbes are immobilized in these traps, which contain a lethal concentration of antimicrobial agents killing a broad range of microorganisms, including gram-negative and gram-positive bacteria, fungi, viruses, and protozoa (Brinkmann et al., 2004, Fuchs et al., 2010, Camicia et al., 2014).
The role of NETs in pediatric infection is not well understood. We hypnotize that children are capable of forming NETs and that NETosis plays an important role in pediatric sepsis. This study is designed to assess the role of neutrophil extracellular traps (NETs) in neonatal and pediatric sepsis as well as to evaluate markers of NETs formation as early predictors of neonatal and pediatric sepsis.
1,899 studies on the registry are indexed under Sepsis; 458 are open to participants now.
This study's planned enrollment of 200 is above the median of 160 across 929 observational studies indexed under Sepsis.
Browse Sepsis studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All children with suspected sepsis
Inclusion Criteria:
For infants below 44 weeks inclusive of corrected age clinical sepsis is defined, according to the Expert Meeting on Neonatal and Pediatric Sepsis (Report on the Expert Meeting on Neonatal and Pediatric Sepsis - 8 June 2010, EMA London). Confirmed sepsis is defined as positive culture for pathogens in a sample from a normally sterile site and at least one laboratory sign or clinical sign (not shown) For children above 44 weeks corrected age clinical sepsis is defined according to the Goldstein criteria (Goldstein et al, 2005). Confirmed sepsis: positive culture for pathogens in a sample from a normally sterile site and at least one laboratory sign or clinical sign (not shown)
Other: Markers of NET formation
None of the above.
Other: Markers of NET formation
i.e. Plasma DNA, Histone, MPO, DNase
Also known as: Typical biomarkers of NETosis
Neutrophil Extracellular Traps
Neutrophil Extracellular Traps are measured by serum markers
Time frame: 2 weeks
Sepsis
Sepsis is defined according to the Goldstein criteria 2015.
Time frame: 2 weeks
This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Hamburg-Eppendorf