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.
Status
Completed
Phase
Phase 4
Enrollment
508
Locations
2
Results
Not posted
Publications
3
Study 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.
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.
Interventions
DRUG
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
Placebo inject will be given at the same dose as Thymosin in addition to the standard treatment.
Timeline
First posted
Jun 16, 2015
Study start
Mar 27, 2018
Primary completion
Dec 24, 2020
Study completion
Mar 24, 2021
Results posted
Not reported
Registry updated
Apr 5, 2021
Outcomes
Occurrence of pancreatic infection:
Time frame · during the index admission
The occurrence of new-onset organ failure and new-onset persistent organ failure
Time frame · during the index admission
(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
In-hospital mortality
Time frame · during the index admission
Bleeding requiring intervention
Time frame · during the index admission
Gastrointestinal perforation or fistula requiring intervention
Time frame · during the index admission
Incidence of pancreatic fistula
Time frame · during the index admission
New receipt of mechanical ventilation/renal replacement therapy /New receipt of vasoactive agents
Time frame · during the index admission
not applied 24 hours before randomization
The requirement for catheter drainage/Number of drainage procedures required
Time frame · during the index admission
The requirement for minimally-invasive debridement/Number of minimally invasive necrosectomy required
Time frame · during the index admission
The requirement for open surgery/Number of open surgery required
Time frame · during the index admission
Length of intensive care unit(ICU) stay/Length of hospital stay
Time frame · during the index admission
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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Jinling Hospital
Nanjing, Jiangsu, China
Publications
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