Current partner codePEPTIDESDE
NCT02473406·Phase 4·INTERVENTIONAL

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

Status

Completed

Phase

Phase 4

Enrollment

508

Locations

2

Results

Not posted

Publications

3

Study summary

What the protocol is testing.

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.

Full detailed 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.

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Jun 16, 2015

  2. Study start

    Mar 27, 2018

  3. Primary completion

    Dec 24, 2020

  4. Study completion

    Mar 24, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Apr 5, 2021

Outcomes

What the study measures.

Primary outcomes

Occurrence of pancreatic infection:

Time frame · during the index admission

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

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

2 registered sites.

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

Results and literature.

Primary links

Continue at the source.

Related trials

More studies on Thymosin Alpha-1.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.