Thymosin Alpha 1 in the PRevention of PAncreatic InfeCtion Following Acute NEcrotizing Pancreatitis: a Double-Blinded Multi-centered, Randomized Control Trial

 

Version: V2.0
Target number of participants:540
Trial status:Recruitment
Condition category:pancreatitis, infection, critical illness

Summary

Infected pancreatic necrosis (IPN) and its related septic complications are the major causes of death in patients with acute necrotizing pancreatitis(ANP). Immunosuppression and disorders characterized by decreased HLA-DR expression and unbalanced CD3/CD4+/CD8+ T cells of peripheral blood mononuclear cell (PBMC) are reported to be associated with the development of IPN. Thymosin alpha 1 has been shown to have immunomodulatory properties and is reported to be beneficial in patients with sepsis. However, the effect of thymosin alpha 1 in patients with AP is rarely reported in the literature.
We conducted an investigator-initiated, randomized, multi-centered, double-blinded, placebo-controlled comparison study to evaluate the efficacy of Thymosin Alpha 1 in prevention of IPN and its impact on immune function and other clinical outcomes in patients with ANP.
The present clinical interventional study will be performed in 16 different ICUs across China. We plan to recruit 540 patients. After the initial enrollment, participants will be randomly assigned in a 1:1 ratio to either the treatment group or the control group in a double-blinded manner according to internet-based computer-generated random numbers in block sizes of 4. The random assignment will be conducted by a third party independent of the study, and the assignment records will not be disclosed until the end of the study.
Arm#1 Thymosin Group
In addition to the standard treatment, thymosin therapy will be started after admission: 1.6mg I.H q12h for the first 7 days and 1.6mg I.H, qd for the following 7 days or until discharge.
Arm#2 Control group
Placebo inject will be given at the same dose as Thymosin in addition to the standard treatment.

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