Sepsis Sepsis
Conditions
Interventions
Zinc replacement therapy
Novelzine 100 mg daily: 50 mg twice daily for 7 days.
Zinc
Sponsors
Inoue Shigeaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 18 years or older at the time consent is obtained. 2) Any gender. 3) Meet the sepsis criteria of SEPSIS-3. 4) Written consent for this study was obtained from the subject or a surrogate. 5) Patients who are expected to survive for 2 weeks. Appendix: SEPSIS3 Sepsis Criteria Suspected infection and an increase in total SOFA score of at least 2 points
Exclusion criteria
Exclusion criteria: 1) Patients with a history of hypersensitivity to the study drug 2) Patients with cardiopulmonary arrest at the time of admission 3) Patients who do not wish to undergo active treatment at the time of diagnosis at the request of the patient or family 4) Patients deemed inappropriate for study inclusion by the principal investigator 5) Patients on immunosuppressive drugs 6) Patients using drugs that affect lymphocyte counts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peripheral blood lymphocyte count at Day15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Peripheral blood lymphocyte count at each time point (Day1,8,29) N/L ratio at each time point (Day1,8,15,29) Peripheral blood zinc concentration at each time point (Day1,8,15,29) Peripheral blood copper concentration at each time point (Day1,8,15,29) Safety endpoints (disease Safety endpoints (disease, etc.) Samples should be collected for preservation so that functional analysis of lymphocytes can be performed as an exploratory position. | — |
Contacts
Public ContactShigeaki Inoue
Kobe University hospital
Outcome results
None listed