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

Pancreatitis, Acute Necrotizing Clinical Trial

— TRACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473406
• Other study ID #: TRACE trial
• Status: Completed
• Phase: Phase 4
• Start date: March 27, 2018
• Est. completion date: March 24, 2021

Study information

• Verified date: April 2021
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study Background & Rationale:

Infected pancreatic necrosis and its related septic complications are the major cause of death in patients with acute pancreatitis1, 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 infection2, 3. Thymosin alpha 1 has been shown to have immunomodulatory properties and its effects in preventing pancreatic infection was not well studied4.

Aim of This Study:

To evaluate the effects of TA1 use in the early phase on preventing pancreatic infection, immunomodulation and clinical outcomes in patients with AP.

Sample Size Estimation:

The prevalence of pancreatic infection was reported to be around 25% in AP episodes. To demonstrate a 40% reduction in the prevalence of pancreatic infection with 80% power at a two-sided alpha level of .05, we projected an estimated sample size of 500 participants. Considering possible 2% withdraw, we plan to randomize 510 patients in total.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: March 24, 2021
• Est. primary completion date: December 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Acute Necrotizing

Intervention

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

Locations

Country	Name	City	State
China	Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China	Nanjing	Jiangsu
China	Jinling Hospital	Nanjing	Jiangsu

Sponsors (16)

Lead Sponsor

Collaborator

Weiqin Li

Clinical Medical College of Yangzhou University, Jiangsu Province Hospital of Traditional Chinese Medicine, Luoyang Central Hospital, Qilu Hospital of Shandong 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, the Second Affiliated Hospital of Nantong University, Yijishan Hospital of Wannan Medical College, Zhejiang Provincial People's Hospital, Zunyi Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of pancreatic infection:		during the index admission
Secondary	The occurrence of new-onset organ failure and new-onset persistent organ failure	(SOFA score for respiration, cardiovascular, or renal system =2 ). New-onset is defined as events that occur after randomization and not present 24 hours before randomization	during the index admission
Secondary	In-hospital mortality		during the index admission
Secondary	Bleeding requiring intervention		during the index admission
Secondary	Gastrointestinal perforation or fistula requiring intervention		during the index admission
Secondary	Incidence of pancreatic fistula		during the index admission
Secondary	New receipt of mechanical ventilation/renal replacement therapy /New receipt of vasoactive agents	not applied 24 hours before randomization	during the index admission
Secondary	The requirement for catheter drainage/Number of drainage procedures required		during the index admission
Secondary	The requirement for minimally-invasive debridement/Number of minimally invasive necrosectomy required		during the index admission
Secondary	The requirement for open surgery/Number of open surgery required		during the index admission
Secondary	Length of intensive care unit(ICU) stay/Length of hospital stay		during the index admission
Secondary	SOFA score/ CRP level/ HLA-DR level/ Lymphocyte count		on day0, day7, and day14
Secondary	In-hospital cost.		during the index admission
Secondary	Incidence of infection within 90 days after enrollment		90 days after enrollment
Secondary	Mortality within 90 days after enrollment		90 days after enrollment