Severe SepsisNCT03996720
Early Identification and Effective Management of Pediatric Sepsis
An observational study of Severe Sepsis and Sepsis, run by Children's Hospital of Fudan University at 4 sites in China.
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. Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- Severe Sepsis, Sepsis, Septic Shock
- How many people
- 175 participants
- Where
- 4 sitesChina
- Study dates
- 1 Oct 2018to 30 Sep 2021
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 18 years
- All sexes
- Child, Adult
Study population: patients with sepsis from four tertiary PICUs in Shanghai
Who may be able to join
- 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
Who cannot join
- patients without informed consent
- discharge within 48 hours
Trial locations and contacts
4 sites in 1 country.
China4 sites
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality
Xinhua Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality
About this study
Official title: Integration of Metabolic and Inflammatory Mediator Profiles as a Potential Diagnostic Approach for Severe Sepsis in PICU
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.
Read the 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.
- Conditions
- Severe Sepsis, Sepsis, Septic Shock
- Keywords
- metabolomics, biomarkers, inflammatory mediator profile, MODS, predictive model
- Medical subject headings
- Sepsis, Shock, Septic, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe sepsis
Sepsis plus one of the following: cardiovascular organ dysfunction OR acute respiratory distress syndrome OR two or more other organ dysfunctions
Measured: 28 day
Death
death
Measured: 28 day
Secondary outcomes (2)
secondary infection
infection acquired 48h after PICU admission
Measured: 28 day
length of ICU stay
from PICU admission to discharge
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Oct 2018
- Primary completion30 Jun 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Children's Medical Center, Shanghai Children's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Guoping Lu, MD, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996720
- Sponsor's protocol ID
- fdpicu-04
- Status last verified
- Oct 2021
- First submitted
- 21 Jun 2019
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Y, Zhang C, Liu T, Yu Z, Wang K, Ying J, Wang Y, Zhu T, Li J, Hu XL, Zhou Y, Lu G. Malat1 regulates PMN-MDSC expansion and immunosuppression through p-STAT3 ubiquitination in sepsis. Int J Biol Sci. 2024 Feb 11;20(4):1529-1546. doi: 10.7150/ijbs.92267. eCollection 2024.
PubMed 38385073
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Metabolic and Inflammatory Mediator Profiles as a Potential Diagnostic Approach for Severe Sepsis in PICU
- ClinicalTrials.gov ID
- NCT03996720
- Acronym / sponsor ID
- fdpicu-04
- Conditions
- Severe Sepsis, Sepsis, Septic Shock
- Keywords
- metabolomics, biomarkers, inflammatory mediator profile, MODS, predictive model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Children's Medical Center, Shanghai Children's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- patients with sepsis from four tertiary PICUs in Shanghai
Key inclusion criteria (6 listed)
- The presence of at least two of the following four criteria, one of which must be abnormal temperature or leukocyte count:
- 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
Key exclusion criteria (2 listed)
- patients without informed consent
- discharge within 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
secondary infection
Time frame: 28 day
length of ICU stay
Time frame: 28 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Derived from this study: PubMed 38385073Wang Y, Zhang C, Liu T, Yu Z, Wang K, Ying J, Wang Y, Zhu T, Li J, Hu XL, Zhou Y, Lu G. Malat1 regulates PMN-MDSC expansion and immunosuppression through p-STAT3 ubiquitination in sepsis. Int J Biol Sci. 2024 Feb 11;20(4):1529-1546. doi: 10.7150/ijbs.92267. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoping Lu, MD principal investigator
Children's Hospital of Fudan University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Sepsis, run by Children's Hospital of Fudan University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe sepsis (time frame: 28 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03996720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.