Skip to content

Study on the pathogenesis and diagnosis and treatment system of infection-related cytokine storm syndrome

Study on the pathogenesis and diagnosis and treatment system of infection-related cytokine storm syndrome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300074075
Enrollment
Unknown
Registered
2023-07-28
Start date
2022-07-26
Completion date
Unknown
Last updated
2023-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious disease

Interventions

Hepatophilic viruses such as hepatitis B/Respiratory viruses such as COVID-19/Insect borne pathogens such as Bunia virus/Herpesvirus such as EB virus/Sepsis bacteria such as Klebsiella pneumoniae grou
General medical treatment + artificial liver treatment:General medical treatment+ Artificial liver treatment A single treatment of 3-4 hours, artificial liver treatment every 1-2 days, and the number
General medical treatment + microecological regulation:General medical treatment+ Probiotic intervention group was given 2 packs of veroxue twice a day until recovery and discharge.
General medical treatment + immunomodulator:General medical treatment+ Immunomodulators (such as immune antibodies, adrenal glucocorticoids, etc.) were given according to the stratified grading of pat
Comprehensive treatment:Artificial liver, microecological preparations, immunomodulators+ General medical treatment
Control group:General medical treatment

Sponsors

The First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Infected patients with an etiological basis such as biological sample culture or nucleic acid 2. Increased circulating cytokines (5 times or more of any one cytokine) 3. Meet the diagnostic criteria for systemic inflammatory syndrome (meet any two criteria: body temperature above 38 degrees Celsius or below 36 degrees Celsius; Heart rate > 90 beats/min; Respiration rate more than 20 times/min or CO2 partial pressure less than 32 mmHg;White blood cell count > 12000/µL or 10%.); 4. SOFA score of any organ (liver, kidney, brain, respiratory, circulation, coagulation) is greater than or equal to 1.

Exclusion criteria

Exclusion criteria: The first part of the observational study: 1. Under the age of 15; 2. Pregnant women; 3. Malignant tumor; 4. Active stage of inflammatory diseases and rheumatic immune diseases; 5. Used CAR T or other cell biotherapy in the last six months. The fifth part of the intervention study: 1.Pregnant women; 2.The patient or family member does not agree to sign the informed consent; 3.There are comorbidities, such as malignant tumors or long-term immunosuppressants, which affect the evaluation of the efficacy of this treatment; 4.The investigators determined that the patient had other conditions that were not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
cytokines;Part I: 28-day case fatality rate;Part 5:28-day severe/critical case fatality rate;Part Five: Improvement rate;

Secondary

MeasureTime frame
Immune cell subsets;Metabolite;Microbiomics;Part I: Incidence of organ failure within 28 days;Part Five: Incidence of shock;Part Five: The incidence of multiple organ failure;Part Five: Length of stay;Part Five: Length of stay in ICU;

Countries

China

Contacts

Public ContactKaijin Xu

The First Affiliated Hospital, College of Medicine, Zhejiang University

zdyxyxkj@zju.edu.cn+86 137 5087 0030

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026