NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051220200

Registered date:23/03/2023

Effects of Zinc Supplementation on Improving Immune Function in Patients with Sepsis

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedSepsis
Date of first enrollment23/03/2023
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Zinc replacement therapy Novelzine 100 mg daily: 50 mg twice daily for 7 days.

Outcome(s)

Primary OutcomePeripheral blood lymphocyte count at Day15
Secondary OutcomePeripheral 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.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1) 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
Exclude criteria1) 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

Related Information

Contact

Public contact
Name Shigeaki Inoue
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo Hyogo Japan 650-0017
Telephone +81-78-385-6521
E-mail inoues@med.kobe-u.ac.jp
Affiliation Kobe University hospital
Scientific contact
Name Shigeaki Inoue
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo Hyogo Japan 650-0017
Telephone +81-78-382-6521
E-mail inoues@med.kobe-u.ac.jp
Affiliation Kobe University hospital