Thymosin Alpha 1 in the Prevention of Pancreatic Infection Following Acute Necrotizing Pancreatitis

Summary

Infected pancreatic necrosis and its related septic complications are the major cause of death in patients with acute pancreatitis, therefore prevention of pancreatic infection is of great clinical value in the treatment of AP.

Immunosuppression and disorders characterized by decreased HLA-DR expression and unbalanced CD3/CD4+/CD8+ T cells of PBMC are thought to be associated with the development of pancreatic infection. Thymosin alpha 1 has been shown to have immunomodulatory properties and its effects in preventing pancreatic infection was not well studied. To evaluate the effects of TA1 use in the early phase on preventing pancreatic infection, immunomodulation and clinical outcomes in patients with AP,we aimed to design this study.

Conditions

• Pancreatitis, Acute Necrotizing

Interventions

DRUG

Thymosin Alpha 1

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.

DRUG

normal saline

Placebo inject will be given at the same dose as Thymosin in addition to the standard treatment.

Sponsors & Collaborators

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Zunyi Medical College

  collaborator OTHER

• the Affiliated Nanhua Hospital, University of South China

  collaborator UNKNOWN

• Second Affiliated Hospital of Nantong University

  collaborator OTHER

• Wannan Medical College Yijishan Hospital

  collaborator OTHER

• the 908th Hospital of Chinese People's Liberation Army Joint Logistic Support Force

  collaborator UNKNOWN

• Jiangsu Province Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Zhejiang Provincial People's Hospital

  collaborator OTHER

• Luoyang Central Hospital

  collaborator OTHER

• The Affiliated Hospital of Henan University of Science and Technology

  collaborator UNKNOWN

• Clinical Medical College of Yangzhou University

  collaborator UNKNOWN

• The First People's Hospital of Shangqiu

  collaborator UNKNOWN

• Qilu Hospital of Shandong University

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Weiqin Li

  lead OTHER

Principal Investigators

• Li Weiqin, M.D. · Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, Chin

• Ke Lu, M.D. · Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, Chin

• Zhou Jing, M.D. · Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, Chin

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-27

Primary Completion

2020-12-24

Completion

2021-03-24

Countries

• China

Study Locations