Sepsis Clinical Trial
Official title:
Integration of Metabolic and Inflammatory Mediator Profiles as a Potential Diagnostic Approach for Severe Sepsis in PICU
Verified date | October 2021 |
Source | Children's Hospital of Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 175 |
Est. completion date | September 30, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | 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, ß-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 |
Country | Name | City | State |
---|---|---|---|
China | Children's Hospital of Fudan University | Shanghai | Shanghai |
China | Children's Hospital of Shanghai | Shanghai | Shanghai |
China | Shanghai Children's Medical Center | Shanghai | Shanghai |
China | Xinhua Hospital Affiliated to Shanghai Jiaotong University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Fudan University | Shanghai Children's Hospital, Shanghai Children's Medical Center, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severe sepsis | Sepsis plus one of the following: cardiovascular organ dysfunction OR acute respiratory distress syndrome OR two or more other organ dysfunctions | 28 day | |
Primary | Death | death | 28 day | |
Secondary | secondary infection | infection acquired 48h after PICU admission | 28 day | |
Secondary | length of ICU stay | from PICU admission to discharge | 28 day |
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