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Prognosis of immunomodulatory therapy based on the sepsis clinical classification system of M1/M2/Mreg

Prognosis of immunomodulatory therapy based on the sepsis clinical classification system of M1/M2/Mreg

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036191
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

sepsis

Interventions

high inflammation group:Methylprednisolone 40 mg twice a day for 5 days or until out of ICU or death
immunosuppression group:One alpha thymosin peptide once a day for 5 days or until out of ICU or death
low inflammation group:no intervention
no immunosuppression:no intervention

Sponsors

Renji Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Meet sepsis 3.0 diagnostic criteria (clinically clear infection and SOFA >= 2 points); 2. Aged >= 18 years, no gender limit; 3. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Aged > 80 years; 2. HIV infection; 3. Receiving anti-tumor chemotherapy in the last three months; 4. Being receiving immunosuppressive treatment due to organ transplantation and immune diseases; 5. Allogeneic bone marrow suppression or stem cell transplantation; 6. Use hormone therapy in the past three months (0.5mg/kg prednisone or equivalent other hormones for more than 30 days).

Design outcomes

Primary

MeasureTime frame
M1/M2/Mreg level;Key RNA levels in macrophages;Existing clinical immune function indicators;

Secondary

MeasureTime frame
APACHE II score;SOFA;

Countries

China

Contacts

Public ContactYuan Gao

Renji Hospital, Shanghai Jiaotong University School of Medicine

rj_gaoyuan@163.com+86 13651672480

Outcome results

None listed

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