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

• Status: Completed
• Trial end date: 2021-03-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weiqin Li
• Collaborators: Clinical Medical College of Yangzhou University; Jiangsu Province Hospital of Traditional Chinese Medicine; Luoyang Central Hospital; Qilu Hospital of Shandong University; Second Affiliated Hospital of Nantong University; the 908th Hospital of Chinese People's Liberation Army Joint Logistic Support Force; The Affiliated Hospital of Henan University of Science and Technology; The Affiliated Hospital of Qingdao University; the Affiliated Nanhua Hospital, University of South China; The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Nanchang University; The First People's Hospital of Shangqiu; Yijishan Hospital of Wannan Medical College; Zhejiang Provincial People's Hospital; Zunyi Medical College
• Treatments: Thymalfasin

Criteria

Inclusion criteria

1. Symptoms and signs of acute pancreatitis based on abdominal pain suggestive of AP, serum amylase at least three times the upper limit of normal, and/or characteristic findings of AP on computed tomography or less commonly magnetic resonance imaging (MRI) or transabdominal ultrasonography according to the Revised Atlanta Criteria[15];

2. Less than one week from the onset of abdominal pain;

3. Age between 18 to 70 years old;

4. Acute Physiology and Chronic Health Evaluation(APACHE II) score ≥8 during the last 24 hours before enrollment

5. Balthazar CT score ≥5 (presence of pancreatic necrosis)[16].

6. Written informed consent obtained

Exclusion criteria

1. Pregnant pancreatitis;

2. History of chronic pancreatitis；

3. Malignancy related acute pancreatitis

4. Receiving early intervention or surgery due to abdominal compartment syndrome or other reasons before admission；

5. Patients with a known history of severe cardiovascular, respiratory, renal or hepatic diseases defined as (1) greater than New York Heart Association Class II heart failure(Class II not included), (2) active myocardial ischemia or (3) cardiovascular intervention within previous 60 days, (4) history of cirrhosis or (5) chronic kidney disease with creatinine clearance< 40 mL/min, or (6) chronic obstructive pulmonary disease with requirement for home oxygen;

6. Patients with preexisting immune disorders such as AIDS.