Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass

Nanjing Medical University200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

200

Conditions

Rheumatic Heart Disease Cardiopulmonary Bypass Immunotherapy

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The highest Sequential Organ Failure Assessment (SOFA) score of 5 days after surgery

Time frame: 5 days after surgery

Secondary Outcomes

30-day mortality

Death from any cause of 30 days after randomization

Time frame: 30 days after randomization