Critical IllnessNCT04850456
Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm
An observational study of Critical Illness and Sepsis, Severe, run by Children's Hospital of Fudan University at 2 sites in China.
Trial summary
The inflammatory storm in critically ill patients releases cytokines, causing systemic immune damage, which may be an important cause of multiple organ failure and even death. Inflammatory storms exacerbate the deterioration of the disease in those children. Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- Critical Illness, Sepsis, Severe
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult
Study population: All children hospitalized in PICU of Children's Hospital of Fudan University from January 2022 to December 2023
Who may be able to join
- children hospitalized in PICU of Children's Hospital of Fudan University
- Children With Severe Infection Complicated With Inflammatory Storm
Who cannot join
- discharge within 48 hours
- patients without informed consent
- incomplete clinical and demographic data
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality
Guoping Lu, MD, +86 18017590817, 13788904150@163.com
- Recruiting
Children's Hospital of Fudan University
Shanghai, 201102
Guoping Lu, +86 18017590817, 13788904150@163.com
About this study
Official title: Treatment Strategy of Human Gamma Globulin in Children With Severe Infection Complicated With Inflammatory Storm : A Cohort Study
The inflammatory storm in critically ill patients releases cytokines, causing systemic immune damage, which may be an important cause of multiple organ failure and even death. Inflammatory storms exacerbate the deterioration of the disease in those children. Gamma globulin may be an effective option to control inflammatory storms. However, this preliminary result needs to be verified from reliable and representative RCTs. In our study, we conducted a retrospective study on the use of gamma globulin and an unused control group. At present, the indications of IVIG are mainly focused on the neuromuscular system and the blood system. We hope to establish a more appropriate and operable evaluation table for the suitability of gamma globulin for clinical use.
Read the detailed description
In severe infective patients who survive the initial inflammatory storm, the immune response often evolves toward a state of immunosuppression, which contributes to increased mortality and severe secondary hospital-acquired infections. However, the role of gamma globulin therapy in patients with severe infection including sepsis and septic shock is discussed controversially. We intend to retrospectively analyze the efficacy and application evaluation of gamma globulin in severely infected children hospitalized in the intensive care unit. Clinical and demographic data, as well as treatment outcome will be collected from the electronic health record. It is expected to provide evaluation basis for clinicians to formulate treatment plans and clinical pharmacists for special comments on the clinical use of gamma globulin.
- Conditions
- Critical Illness, Sepsis, Severe
- Keywords
- Sepsis, Critical Illness, Inflammatory Storm, Gamma Globulin
- Medical subject headings
- Critical Illness, Sepsis
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 |
|---|---|---|
| trial group | Human Gamma Globulin | |
| control group | conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The death rate of children
The death rate of children in 28 days after their discharged from PICU
Measured: within 28 days after they discharged from PICU
length of stay in PICU
Time from PICU admission to discharge
Measured: up to 28 days
Secondary outcomes (9)
CD4+/CD8+
levels of peripheral blood subgroup of T lymphocyte (digital form)
Measured: Within 3 to 15 days after the start of treatment
C-reactive protein (CRP)
C-reactive protein (digital form)
Measured: Within 3 to 15 days after the start of treatment
IL-2R
The interleukin-2 receptor (digital form)
Measured: Within 3 to 15 days after the start of treatment
TNF-alpha
Tumor necrosis factor alpha (digital form)
Measured: Within 3 to 15 days after the start of treatment
Treg
levels of peripheral blood subgroup of T lymphocyte (digital form)
Measured: Within 3 to 15 days after the start of treatment
IL-6
The interleukin-6 (digital form)
Measured: Within 3 to 15 days after the start of treatment
IFN-gamma
Interferon gamma (digital form)
Measured: Within 3 to 15 days after the start of treatment
Procalcitonin (digital form)
Procalcitonin (digital form)
Measured: Within 3 to 15 days after the start of treatment
IL-10
The interleukin-10 (digital form)
Measured: Within 3 to 15 days after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850456
- Sponsor's protocol ID
- fdpicu-16
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2021
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Strategy of Human Gamma Globulin in Children With Severe Infection Complicated With Inflammatory Storm : A Cohort Study
- ClinicalTrials.gov ID
- NCT04850456
- Acronym / sponsor ID
- fdpicu-16
- Conditions
- Critical Illness, Sepsis, Severe
- Keywords
- Sepsis, Critical Illness, Inflammatory Storm, Gamma Globulin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Apr 2021 (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.
The inflammatory storm in critically ill patients releases cytokines, causing systemic immune damage, which may be an important cause of multiple organ failure and even death. Inflammatory storms exacerbate the deterioration of the disease in those children. Gamma globulin may be an effective option to control inflammatory storms. However, this preliminary result needs to be verified from reliable and representative RCTs. In our study, we conducted a retrospective study on the use of gamma globulin and an unused control group. At present, the indications of IVIG are mainly focused on the neuromuscular system and the blood system. We hope to establish a more appropriate and operable evaluation table for the suitability of gamma globulin for clinical use.
Detailed description
In severe infective patients who survive the initial inflammatory storm, the immune response often evolves toward a state of immunosuppression, which contributes to increased mortality and severe secondary hospital-acquired infections. However, the role of gamma globulin therapy in patients with severe infection including sepsis and septic shock is discussed controversially. We intend to retrospectively analyze the efficacy and application evaluation of gamma globulin in severely infected children hospitalized in the intensive care unit. Clinical and demographic data, as well as treatment outcome will be collected from the electronic health record. It is expected to provide evaluation basis for clinicians to formulate treatment plans and clinical pharmacists for special comments on the clinical use of gamma globulin.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trial group | – | –Human Gamma Globulin |
| control group | – | –conventional treatment |
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children hospitalized in PICU of Children's Hospital of Fudan University from January 2022 to December 2023
Key inclusion criteria (2 listed)
- children hospitalized in PICU of Children's Hospital of Fudan University
- Children With Severe Infection Complicated With Inflammatory Storm
Key exclusion criteria (3 listed)
- discharge within 48 hours
- patients without informed consent
- incomplete clinical and demographic data
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
The death rate of children
Time frame: within 28 days after they discharged from PICU
The death rate of children in 28 days after their discharged from PICU
length of stay in PICU
Time frame: up to 28 days
Time from PICU admission to discharge
9 secondary outcomes
CD4+/CD8+
Time frame: Within 3 to 15 days after the start of treatment
C-reactive protein (CRP)
Time frame: Within 3 to 15 days after the start of treatment
IL-2R
Time frame: Within 3 to 15 days after the start of treatment
TNF-alpha
Time frame: Within 3 to 15 days after the start of treatment
Treg
Time frame: Within 3 to 15 days after the start of treatment
IL-6
Time frame: Within 3 to 15 days after the start of treatment
IFN-gamma
Time frame: Within 3 to 15 days after the start of treatment
Procalcitonin (digital form)
Time frame: Within 3 to 15 days after the start of treatment
IL-10
Time frame: Within 3 to 15 days after the start of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Sepsis, Severe, run by Children's Hospital of Fudan University at 2 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoping Lu, Doctor (13788904150, 13788904150@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The death rate of children (time frame: within 28 days after they discharged from PICU). 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?
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 16 Mar 2026.