Rheumatic Heart Disease, Cardiopulmonary Bypass, Immunotherapy
Conditions
Brief summary
Rheumatic heart disease usually accompanied by weakened immune function. And the cardiopulmonary bypass further aggravating the decline of immune function. Therefore, the prevention of Postoperative immune function collapse is of great clinical value, and immunomodulatory therapy with thymosin alpha 1 may be beneficial. This study was designed to test the hypothesis that the administration of thymosin alpha 1 will Improve the immune function and prognosis of patients.
Interventions
DRUGThymosin Alpha1
Thymosin alpha 1, 1.6mg injection hypodermic (I.H), every 12 hours for 5 days at least during the ICU admission. The administration will be terminated any day during the treatment when the patient is deemed as qualified for ICU discharge or dead
OTHERBlank Control
the Control group did not receive Thymosin alpha 1 or any placebo.
Sponsors
Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* The patients are conformed to 2004 WHO guidelines for Rheumatic fever and rheumatic heart disease; * Patients planning to undergo cardiac surgery were enrolled. * The patients' age between 18 \ 80 years old. * Agree to participate in the study and sign the informed consent.
Exclusion criteria
* Patients allergic to Thymosin α1; * Lactating women and pregnant women; * Patients with mental diseases, drug and alcohol dependence; * Refuse to participate in this study and refuse to sign the informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The highest Sequential Organ Failure Assessment (SOFA) score of 5 days after surgery | 5 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day mortality | 30 days after randomization | Death from any cause of 30 days after randomization |
Countries
China
Contacts
Primary ContactHong Liu, MD
Backup ContactSheng Zhao, MD
Outcome results
None listed