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Clinical Trials/NCT02567305
NCT02567305
Unknown
Not Applicable

Neutrophil Extracellular Traps and Neonatal (PV4991) & Pediatric Sepsis (PV5063)

Universitätsklinikum Hamburg-Eppendorf2 sites in 1 country200 target enrollmentSeptember 2015
ConditionsSepsis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sepsis
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
200
Locations
2
Primary Endpoint
Neutrophil Extracellular Traps
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
January 2020
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Signed informed consent by the parent or guardian of the patient
  • Chronological age below 90 days (= neonatal branch) or below 18 years (pediatric branch)
  • Suspicion of sepsis infection

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Neutrophil Extracellular Traps

Time Frame: 2 weeks

Neutrophil Extracellular Traps are measured by serum markers

Secondary Outcomes

  • Sepsis(2 weeks)

Study Sites (2)

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