Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04850456
Other study ID # fdpicu-16
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date December 31, 2025

Study information

Verified date February 2024
Source Children's Hospital of Fudan University
Contact Guoping Lu, Doctor
Phone 13788904150
Email 13788904150@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 29 Days to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Children's Hospital of Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The death rate of children The death rate of children in 28 days after their discharged from PICU within 28 days after they discharged from PICU
Primary length of stay in PICU Time from PICU admission to discharge up to 28 days
Secondary CD4+/CD8+ levels of peripheral blood subgroup of T lymphocyte (digital form) Within 3 to 15 days after the start of treatment
Secondary C-reactive protein (CRP) C-reactive protein (digital form) Within 3 to 15 days after the start of treatment
Secondary IL-2R The interleukin-2 receptor (digital form) Within 3 to 15 days after the start of treatment
Secondary TNF-alpha Tumor necrosis factor alpha (digital form) Within 3 to 15 days after the start of treatment
Secondary Treg levels of peripheral blood subgroup of T lymphocyte (digital form) Within 3 to 15 days after the start of treatment
Secondary IL-6 The interleukin-6 (digital form) Within 3 to 15 days after the start of treatment
Secondary IFN-gamma Interferon gamma (digital form) Within 3 to 15 days after the start of treatment
Secondary Procalcitonin (digital form) Procalcitonin (digital form) Within 3 to 15 days after the start of treatment
Secondary IL-10 The interleukin-10 (digital form) Within 3 to 15 days after the start of treatment
See also
  Status Clinical Trial Phase
Completed NCT04551508 - Delirium Screening 3 Methods Study
Recruiting NCT06037928 - Plasma Sodium and Sodium Administration in the ICU
Completed NCT03671447 - Enhanced Recovery After Intensive Care (ERIC) N/A
Recruiting NCT03941002 - Continuous Evaluation of Diaphragm Function N/A
Recruiting NCT04674657 - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Completed NCT04239209 - Effect of Intensivist Communication on Surrogate Prognosis Interpretation N/A
Completed NCT05531305 - Longitudinal Changes in Muscle Mass After Intensive Care N/A
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Completed NCT02916004 - The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients. N/A
Recruiting NCT05883137 - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed NCT04479254 - The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study) N/A
Recruiting NCT04475666 - Replacing Protein Via Enteral Nutrition in Critically Ill Patients N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A
Withdrawn NCT04043091 - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction N/A
Recruiting NCT02922998 - CD64 and Antibiotics in Human Sepsis N/A
Recruiting NCT02989051 - Fluid Restriction Keeps Children Dry Phase 2/Phase 3
Completed NCT02899208 - Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients? N/A
Completed NCT03048487 - Protein Consumption in Critically Ill Patients
Recruiting NCT02163109 - Oxygen Consumption in Critical Illness