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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03996720
Other study ID # fdpicu-04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date September 30, 2021

Study information

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]

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

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

Sponsors (4)

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

Country where clinical trial is conducted

China, 

Outcome

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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