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出境医 / 临床实验 / Early Identification and Effective Management of Pediatric Sepsis
Early Identification and Effective Management of Pediatric Sepsis
Study Description
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.
| Condition or disease |
|---|
| Severe Sepsis Sepsis Septic Shock |
Detailed 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.
Study Design
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 28 Days |
| Official Title: | Integration of Metabolic and Inflammatory Mediator Profiles as a Potential Diagnostic Approach for Severe Sepsis in PICU |
| Actual Study Start Date : | October 1, 2018 |
| Estimated Primary Completion Date : | April 30, 2021 |
| Estimated Study Completion Date : | June 30, 2021 |
Arms and Interventions
| Group/Cohort |
|---|
|
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
|
Outcome Measures
Primary Outcome Measures :
- 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
- Death [ Time Frame: 28 day ]death
Secondary Outcome Measures :
- secondary infection [ Time Frame: 28 day ]infection acquired 48h after PICU admission
- length of ICU stay [ Time Frame: 28 day ]from PICU admission to discharge
Biospecimen Retention: Samples With DNA
2ml of whole blood collected in sterile tubes containing EDTA
Eligibility Criteria
| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Study Population
patients with sepsis from four tertiary PICUs in Shanghai
Criteria
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
Contacts and Locations
Contacts
| Contact: Guoping Lu, MD | 13788904150 | 13788904150@i63.com | |
| Contact: Chunying Peng | 18258827399 | pengchunying@icloud.com |
Locations
| China, Shanghai | |
| Children's Hospital of Fudan University | Enrolling by invitation |
| Shanghai, Shanghai, China | |
| Children's Hospital of Shanghai | Recruiting |
| Shanghai, Shanghai, China | |
| Contact: Yucai Zhang, MD 18917128301 zhangyc@shchildren.com.cn | |
| Shanghai Children's Medical Center | Recruiting |
| Shanghai, Shanghai, China | |
| Contact: Ying Wang, MD 18930830600 ywangpicu@shsmu.edu.cn | |
| Xinhua Hospital Affiliated to Shanghai Jiaotong University | Recruiting |
| Shanghai, Shanghai, China | |
| Contact: Xiaodong Zhu, MD 13651727806 zhuxiaodong@xinhuamed.com.cn | |
Sponsors and Collaborators
Children's Hospital of Fudan University
Shanghai Children's Medical Center
Shanghai Children's Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
| Principal Investigator: | Guoping Lu, MD | Children's Hospital of Fudan University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 21, 2019 | ||||||||
| First Posted Date | June 25, 2019 | ||||||||
| Last Update Posted Date | March 15, 2021 | ||||||||
| Actual Study Start Date | October 1, 2018 | ||||||||
| Estimated Primary Completion Date | April 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Early Identification and Effective Management of Pediatric Sepsis | ||||||||
| Official Title | Integration of Metabolic and Inflammatory Mediator Profiles as a Potential Diagnostic Approach for Severe Sepsis in PICU | ||||||||
| 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. | ||||||||
| Detailed 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. | ||||||||
| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | 28 Days | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
2ml of whole blood collected in sterile tubes containing EDTA
|
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | patients with sepsis from four tertiary PICUs in Shanghai | ||||||||
| Condition |
|
||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
200 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | June 30, 2021 | ||||||||
| Estimated Primary Completion Date | April 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | up to 18 Years (Child, Adult) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
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| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03996720 | ||||||||
| Other Study ID Numbers | fdpicu-04 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Children's Hospital of Fudan University | ||||||||
| Study Sponsor | Children's Hospital of Fudan University | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Children's Hospital of Fudan University | ||||||||
| Verification Date | March 2021 | ||||||||
