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OpenTrials
Completed

NCT Number: NCT03996720

Early Identification and Effective Management of Pediatric Sepsis

In patients diagnosed as sepsis on PICU admission, early and accurate identification of patients who will develop organ dysfunction (severe sepsis) is critical for effective management and positive outcome. A multiple marker approach would improve clinical utility compared with use of a single marker. The primary goal of this part of study is to define a combination of multiple markers, derived from novel biomarkers (nCD-64, IL-27, sTREM, HLA-DR, IL-10), metabolomics and routine clinical parameters, which could predict severe sepsis and determine the severity of disease.

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Key information

Age range

29 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Fudan University, Shanghai, Shanghai Municipality, China

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About this study

We intend to enroll pediatric sepsis patients at four PICUs and divide them into two groups based on clinical outcomes: severe sepsis group (patients who progress into severe sepsis), sepsis group (patients who do not progress in to severe sepsis). We intend to perform predictive modeling using multivariable analyses of the novel biomarkers and derive a biomarker panel and algorithm for early diagnosis of severe sepsis. The predictive value of the biomarker panel for early identification of severe sepsis will be compared with established indices, such as PRISM III and pSOFA score.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The presence of at least two of the following four criteria, one of which must be abnormal temperature or leukocyte count:
  • Coreb temperature of >38.5°C or <36°C.
  • Tachycardia, defined as a mean heart rate >2 SD above normal for age in the absence of external stimulus, chronic drugs, or painful stimuli; or otherwise unexplained persistent elevation over a 0.5- to 4-hr time period OR for children <1 yr old: bradycardia, defined as a mean heart rate <10th percentile for age in the absence of external vagal stimulus, β-blocker drugs, or congenital heart disease; or otherwise unexplained persistent depression over a 0.5-hr time period.
  • Mean respiratory rate >2 SD above normal for age or mechanical ventilation for an acute process not related to underlying neuromuscular disease or the receipt of general anesthesia.
  • Leukocyte count elevated or depressed for age (not secondary to chemotherapy-induced leukopenia) or >10% immature neutrophils
  • A suspected or proven (by positive culture, tissue stain, or polymerase chain reaction test) infection caused by any pathogen OR a clinical syndrome associated with a high probability of infection. Evidence of infection includes positive findings on clinical exam, imaging, or laboratory tests

Exclusion criteria

  • patients without informed consent
  • discharge within 48 hours

Treatment and study plan

Primary outcomes

  1. Severe sepsis

    Time frame: 28 day

    Sepsis plus one of the following: cardiovascular organ dysfunction OR acute respiratory distress syndrome OR two or more other organ dysfunctions

  2. Death

    Time frame: 28 day

    death

Secondary outcomes

  1. secondary infection

    Time frame: 28 day

    infection acquired 48h after PICU admission

  2. length of ICU stay

    Time frame: 28 day

    from PICU admission to discharge

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • Shanghai Children's Hospital
  • Shanghai Children's Medical Center
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Registry information

Official study title

Integration of Metabolic and Inflammatory Mediator Profiles as a Potential Diagnostic Approach for Severe Sepsis in PICU

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 25, 2019
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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