Early Identification and Effective Management of Pediatric Sepsis

NCT03996720 | Completed

• 1 other identifier: fdpicu-04
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Severe Sepsis; Sepsis; Septic Shock

Keywords

metabolomics; biomarkers; inflammatory mediator profile; MODS; predictive model

Outcome Measures

Primary Outcomes (2)

• 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

• Death

  death

  28 day

Secondary Outcomes (2)

• secondary infection

  28 day

• length of ICU stay

  28 day

Study Arms (2)

severe sepsis

patients who diagnosed as sepsis upon PICU admission and develop organ dysfunction during PICU stay

sepsis

patients recover from sepsis without developing into organ dysfunction

Eligibility Criteria

• Age: 29 Days - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients with sepsis from four tertiary PICUs in Shanghai

You may qualify if:

• 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

You may not qualify if:

• patients without informed consent
• discharge within 48 hours

Sponsors & Collaborators

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

Study Sites (4)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

Children's Hospital of Shanghai

Shanghai, Shanghai Municipality, China

Location

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, China

Location

Xinhua Hospital Affiliated to Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

2ml of whole blood collected in sterile tubes containing EDTA

MeSH Terms

Conditions

Sepsis; Shock, Septic; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Guoping Lu, MD

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 25, 2019
• Study Start: October 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)