Ulinastatin in Severe Acute Pancreatitis
Recruitment status was Recruiting
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Purpose
This study aims to evaluate the effect of ulinastatin in the treatment and prevention of organ failure in severe acute pancreatitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatitis |
Drug: ulinastatin Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Multicenter, Double-bind, Randomised, Placebo Controlled Study of Ulinastatin in Severe Acute Pancreatitis |
- multiple organ dysfunction score [ Time Frame: 8 days ] [ Designated as safety issue: No ]
- onset of (multiple) organ failure after randomized [ Time Frame: 8 days ] [ Designated as safety issue: No ]
- mortality [ Time Frame: 8 days, 14 days and 28 days ] [ Designated as safety issue: No ]
- Incidence of complications [ Time Frame: 8 days, 14 days and 28 days ] [ Designated as safety issue: No ]
- APACHE Ⅱ score [ Time Frame: 8 days ] [ Designated as safety issue: No ]
- Need for surgical intervention [ Time Frame: From admission to discharge ] [ Designated as safety issue: No ]
- Hospital stay and ICU stay [ Time Frame: From admission to discharge ] [ Designated as safety issue: No ]
- CT-scan score [ Time Frame: 8 days, 14 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 350 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ulinastatin group
Regular treatments plus ulinastatin. Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.
|
Drug: ulinastatin
Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.
Other Names:
|
|
Placebo Comparator: placebo group
Regular treatment plus placebo. Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.
|
Drug: placebo
Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.
|
Detailed Description:
About 20% of patients with acute pancreatitis have a severe course, and 10-15% of those with severe acute pancreatitis (SAP) die. Despite improvements in intensive care treatment during past few decades, effective therapies for acute pancreatitis are still limited.
Early deaths (within the first week) due to severe acute pancreatitis are generally caused by massive inflammatory responses which result in multiple organ failure. Although the exact mechanisms which trigger the inflammatory processes are not completely understood, it is generally accepted that autodigestion and activated leukocytes play important roles in the pathogenesis of acute pancreatitis. Activation of digestive enzymes causes pancreatic injury and results in an inflammatory response that is out of proportion to the response of other organs to a similar insult. The acute inflammatory response itself causes substantial tissue damage and may progress beyond the pancreas to a systemic inflammatory response syndrome, multi organ failure, or death.
UTI is a multivalent Kunitz-type serine protease inhibitor that is found in human urine and blood, it can stabilize lysosome membrane and inhibit lysosome function, inhibit the various enzymes and inflammatory response. Previous study proved that it protects against SIRS pathophysiology and subsequent organ damage induced via the modulation of the proinflammatory mediator, as well as chemokines. UTI has been widely used for the treatment and prevention of multiple organ failure in China, but there is few randomized, placebo controlled trial on ulinastatin. A large multicenter, randomized study is warranted. In this study, we aim to evaluate the effect of ulinastatin in the treatment and prevention of organ failure in severe acute pancreatitis with regular treatment in an add-on trial.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of severe acute pancreatitis , severe acute pancreatitis adapted from the Atlanta classification:
Early Prognostic Signs: Ramson signs ≥3, APACHE II score ≥8 Organ Failure and/or Local Complications: Necrosis, Abscess, Pseudocyst;
- Admission within 72h after onset of symptoms of pancreatitis
- 18-70 years old
- Signed the informed consent form
Exclusion Criteria:
- Pre-existing chronic renal insufficiency requiring hemodialysis or peritoneal dialysis
- pre existing heart dysfunction or NYHA classification score above III
- pregnancy or lactation
- Allergy for ulinastatin
- Received an investigational drug or device within 90 days prior to entering study
- serious mentally-ill patients including dementia
- On the verge of death (estimated to be mortal in 12h).
Contacts and Locations| China, Guangdong | |
| The First Affiliated Hospital of Sun Yat-Sen University | Recruiting |
| Guangzhou, Guangdong, China | |
| Contact: Xiangdong Guan, MD carlg@163.com | |
| Principal Investigator: Xiangdong Guan, MD | |
| China, Heilongjiang | |
| The First Clinical College of Harbin University | Recruiting |
| Harbin, Heilongjiang, China | |
| Contact: Hongchi Jiang, MD Jianghc@public.hr.hl.cn | |
| Contact: Bei Sun, MD Sunbei70@tom.com | |
| Principal Investigator: Hongchi Jiang, MD | |
| Principal Investigator: Bei Sun, MD | |
| China, Hubei | |
| Wuhan Union Hospital of China | Recruiting |
| Wuhan, Hubei, China | |
| Contact: Chunyou Wang, MD Chunyouwang52@126.com | |
| Contact: Zhiyong Yang, MD dryzy@163.com | |
| Principal Investigator: Chunyou Wang, MD | |
| Sub-Investigator: Zhiyong Yang, MD | |
| China, Jiangsu | |
| Jiangsu Province Hospital | Recruiting |
| Nanjing, Jiangsu, China | |
| Contact: Yi Miao, MD Miaoyi@njum.edu.cn | |
| Contact: Qiang Li liqiang020202@163.com | |
| Principal Investigator: Yi Miao, MD | |
| Sub-Investigator: Qiang Li, MD | |
| China, Sichun | |
| West China Hospital | Recruiting |
| Chengdu, Sichun, China | |
| Contact: Xubao Liu, MD xbliu@medmail.com.cn | |
| Contact: Gang Mai maigang68@hotmail.com | |
| Principal Investigator: Xubao Liu, MD | |
| Sub-Investigator: Gang Mai, MD | |
| China | |
| Peking Union Medical College Hospital | Recruiting |
| Beijing, China | |
| Contact: Yupei Zhao, MD Zhao8028@263.net | |
| Contact: Dawei Liu, MD dwliu98@yahoo.com | |
| Principal Investigator: Yupei Zhao, MD | |
| Principal Investigator: Dawei Liu, MD | |
| Study Chair: | Yupei Zhao, MD | Peking Union Medical College Hospital |
| Principal Investigator: | Chunyou Wang, MD | Wuhan Union Hospital, China |
More Information
Additional Information:
Publications:
| Responsible Party: | Chunya Zou, Techpool Bio-Pharma Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01132521 History of Changes |
| Other Study ID Numbers: | UTI/SAP-S |
| Study First Received: | May 26, 2010 |
| Last Updated: | October 12, 2010 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Techpool Bio-Pharma Co., Ltd.:
|
ulinastatin severe acute pancreatitis |
Additional relevant MeSH terms:
|
Pancreatitis Pancreatic Diseases Digestive System Diseases Trypsin Inhibitors Urinastatin |
Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013