MedDataX Logo

Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm

NCT ID: NCT04850456

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects and Safety of Infusion of Low-Doses of Methylprednisolone in Early ALI and ARDS in Children

NCT01757899

Acute Lung Injury Acute Respiratory Distress Syndrome
WITHDRAWN PHASE2

Intravenous Immunoglobulin (IVIG) Versus Plasma Exchange (PE) for Ventilated Children With Guillain Barre Syndrome (GBS)

NCT01306578

Guillain Barre Syndrome
COMPLETED NA

Modulation of Systemic Inflammatory Response in Critically Ill Children After Glutamine Supplementation

NCT01367223

Inflammatory Response Multi-organ Failure
COMPLETED PHASE4

Implementation of an Infusion Management Scheme to Improve Patient Outcome in Tertiary Children's Hospitals

NCT05152446

Children,Hospitalized Infusion Infections
TERMINATED NA

A Randomized Trial of GM-CSF in Patients With ALI/ARDS

NCT00201409

Respiratory Distress Syndrome, Adult
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Illness Sepsis, Severe

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

trial group

Human Gamma Globulin

No interventions assigned to this group

control group

conventional treatment

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* children hospitalized in PICU of Children's Hospital of Fudan University
* Children With Severe Infection Complicated With Inflammatory Storm

Exclusion Criteria

* discharge within 48 hours
* patients without informed consent
* incomplete clinical and demographic data
Minimum Eligible Age

29 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Children's Hospital of Fudan University

Shanghai, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Guoping Lu, Doctor

Role: CONTACT

[email protected]
13788904150

Yao Wang

Role: CONTACT

[email protected]
+86 13636547582

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Guoping Lu, MD

Role: primary

[email protected]
+86 18017590817

Guoping Lu

Role: primary

[email protected]
+86 18017590817

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

fdpicu-16

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.
NCT01250782 UNKNOWN PHASE2
Reducing Fasting Time in Children for Sedation
NCT05757882 COMPLETED NA
Efficacy and Mechanisms of GLN Dipeptide in the SICU
NCT00248638 COMPLETED PHASE3
Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency
NCT02094430 COMPLETED PHASE2/PHASE3
Different Doses of IVIG for Kawasaki Disease
NCT02439996 COMPLETED PHASE3
Timing of Initiation of Parenteral Nutrition for Critically Ill Children
NCT04693143 UNKNOWN NA
REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumonia
NCT04468971 COMPLETED PHASE1
Efficacy of IntraVenous ImmunoGlobulins in Toxic Shock Syndromes: a Paediatric Pilot Study
NCT02219165 COMPLETED PHASE2
Efficacy of Corticosteroids in Reducing Renal Scarring in Acute Pyelonephritis in Children
NCT04654507 UNKNOWN PHASE3
Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis
NCT00049764 COMPLETED PHASE3
Ascending Single Dose Study of Rhu-pGelsolin in Patients With Decreased Gelsolin Levels
NCT00671307 COMPLETED PHASE1/PHASE2
Magnesium Sulfate in Pediatric Burn Dressing Changes
NCT07126795 NOT_YET_RECRUITING PHASE1
Enteral Glutamine in Critical Illness
NCT00318331 TERMINATED PHASE2/PHASE3
Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma
NCT03368092 RECRUITING PHASE3
Umbilical Cord Blood Therapy for Children With Global Developmental Delay
NCT01601158 COMPLETED NA
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Intravenous Infusion of GW328267X in Healthy Volunteers
NCT01640990 COMPLETED PHASE1
Management of Shock in Children With SAM or Severe Underweight and Diarrhea
NCT04750070 RECRUITING PHASE3
Feasibility of Aerodigestive Stimulation Therapy Trial
NCT06118697 RECRUITING NA
LASER THERAPY IN GASTRIC STOMA INJURIES OF CHILDREN AND ADOLESCENTS
NCT04863196 UNKNOWN NA
Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage
NCT02274428 COMPLETED PHASE1
Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients
NCT02998931 COMPLETED PHASE3
Impact of 2 Resuscitation Sequences on Management of Simulated Pediatric Cardiac Arrest
NCT05474170 COMPLETED NA
Pharmacokinetic Study of Lipo-PGE1 for Prevention of VOD After HSCT
NCT02338440 UNKNOWN PHASE2/PHASE3
Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy
NCT01239680 COMPLETED NA
Use of Corticosteroids in Children With Cellulitis
NCT02087527 TERMINATED NA