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Long-term Prognosis of Patients With Sepsis After Immunotherapy

Not yet recruiting
Conditions
Long-term Effects of Thymosin Alpha 1 Treatment
Interventions
Registration Number
NCT04901104
Lead Sponsor
Sun Yat-sen University
Brief Summary

Current clinical studies of thymosin α1 for sepsis have focused on short-term outcomes (28-day or 90-day mortality), and lack of clinical data on long-term outcomes (3 year mortality) of patients with sepsis after immunotherapy.

Based on the preliminary clinical study (NCT02867267), this study will conduct long-term follow-up for sepsis patients to provide data support for the long-term prognosis of immunotherapy.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
900
Inclusion Criteria
  • Sepsis patients in the TESTS study Patients who discharged from hospital after recovery
Exclusion Criteria
  • None

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
thymosin α1 groupThymosin Alpha1The patient was treated with thymosin α1 in sepsis
Primary Outcome Measures
NameTimeMethod
three years mortality3 years

Mortality rate of patients treated with thymosin α1 or placebo within 3 years

Secondary Outcome Measures
NameTimeMethod
Recurrence rate of sepsis5 years

Percentage of recurrent sepsis within 5 years of discharge sepsis patients

Five years mortality5 years

Mortality rate of patients treated with thymosin α1 or placebo within 5 years

short form 36 questionnaire1 year

Quality of life of sepsis patients after 1 year of thymosin α1 or placebo treatment

one year mortality1 year

Mortality rate of patients treated with thymosin α1 or placebo within 1 year

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