Ulinastatin in Severe Acute Pancreatitis

Pancreatitis Clinical Trial

Official title:

Multicenter, Double-bind, Randomised, Placebo Controlled Study of Ulinastatin in Severe Acute Pancreatitis

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01132521
• Other study ID #: UTI/SAP-S
• Status: Suspended
• Phase: Phase 4
• First received: May 26, 2010
• Last updated: January 16, 2018
• Start date: June 2010
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Techpool Bio-Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the effect of ulinastatin in the treatment and prevention of organ failure in severe acute pancreatitis.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 252
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pancreatitis

Intervention

Drug:
• ulinastatin
Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.
• placebo
Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	West China Hospital	Chengdu	Sichuan
China	The First Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	The First Clinical College of Harbin University	Harbin	Heilongjiang
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Wuhan Union Hospital of China	Wuhan	Hubei

Sponsors (7)

Lead Sponsor	Collaborator
Techpool Bio-Pharma Co., Ltd.	First Affiliated Hospital, Sun Yat-Sen University, Peking Union Medical College Hospital, The First Affiliated Hospital with Nanjing Medical University, The first clinical college of harbin medical university, West China Hospital, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (3)

Maehara K, Kanayama N, Halim A, el Maradny E, Oda T, Fujita M, Terao T. Down-regulation of interleukin-8 gene expression in HL60 cell line by human Kunitz-type trypsin inhibitor. Biochem Biophys Res Commun. 1995 Jan 26;206(3):927-34. — View Citation

Tsujino T, Komatsu Y, Isayama H, Hirano K, Sasahira N, Yamamoto N, Toda N, Ito Y, Nakai Y, Tada M, Matsumura M, Yoshida H, Kawabe T, Shiratori Y, Omata M. Ulinastatin for pancreatitis after endoscopic retrograde cholangiopancreatography: a randomized, con — View Citation

Wang CY, Zhao YP. Progress of therapeutic effect in severe acute pancreatitis: Mini-review of treatment viewpoints and technique improvements. Chin J Surg 44(13): 872-4, 2006. (Article in Chinese)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	multiple organ dysfunction score		8 days
Primary	onset of (multiple) organ failure after randomized		8 days
Secondary	mortality		8 days, 14 days and 28 days
Secondary	Incidence of complications		8 days, 14 days and 28 days
Secondary	APACHE ? score		8 days
Secondary	Need for surgical intervention		From admission to discharge
Secondary	Hospital stay and ICU stay		From admission to discharge
Secondary	CT-scan score		8 days, 14 days

External Links

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