Multi-center Clinical Study of Early Antibios of Severe Acute Pancreatitis

Pancreatitis,Acute Necrotizing Clinical Trial

Official title:

Escalade or Deseacalade Antibiotic Use in Severe Acute Pancreatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01992198
• Other study ID #: SAP BUNDLE-ANTIBIOTICS
• Secondary ID: 12411950500
• Status: Recruiting
• Phase: Phase 4
• First received: October 31, 2013
• Last updated: November 18, 2013
• Start date: July 2012
• Est. completion date: December 2016

Study information

• Verified date: November 2013
• Source: Ruijin Hospital
• Contact: Erzhen Chen, M.D
• Phone: 86-13901753478
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial Summary

Strategy of antibiotic therapy in SAP,De-escalate (cefoperazone+metronidazole) or Escalate (meropenem) therapy,which one is better.

Description:

SAP is a serious and life-threatening disease and requires intensive and aggressive management of multiple organ failure and severe infectious complications that can develop in these patients. The most common cause of death in patients suffering from severe acute pancreatitis (SAP) is the infection of pancreatic necrosis by enteric bacteria with mortality rates of 30% (range 14- 62%),spurring the discussion of whether or not prophylactic antibiotic administration could be a beneficial approach. Pancreatic infections are more often monomicrobial, especially E. coli in the two first weeks (100% and 62.5%) of onset, with a shift from gram-negative to gram-positive as the pancreatitis progressed.

In order to evaluate the benefit of prophylactic antibiotic application, a number of randomized controlled clinical trials have been published over the past 15 years. Since the results were conflicting and most studies were of low methodological quality and/or statistically underpowered, meta-analyses have been performed to assess this important issue. However, their results ranged from absolutely no effect of antibiotic prophylaxis to positive effects regarding mortality, the incidence of infected pancreatic necrosis and the incidence of extra pancreatic infections.

In order to provide reliable evidence of the effect of antibiotherapy strategy in SAP, we performed a prospective randomized multicenter clinical trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• severe Acute Pancreatitis according to Atlanta criteria revisited in 2012

Exclusion Criteria:

• concurrent sepsis or (peri)pancreatic infection caused by a second disease

• patients with chronic organ failure (chronic renal failure needs kidney replacement, chronic heart failure, decompensate hepatic cirrhosis, chronic obstructive pulmonary disease)

• recurrent or endoscopic retrograde cholangiopancreatography (ERCP), or traumatic or operative pancreatitis

• pregnancy, malignancy or immunodeficiency

• a history of allergy to meropenem, cefoperazone and metronidazole

• a history of antibiotic administration within 48 h prior to enrollment

• possible death within 48 h after enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Acute Necrotizing
• Pancreatitis,Acute Necrotizing

Intervention

Drug:
• cefoperazone + metronidazole
1.Clinical parameters (2 of 3): 1)temperature<37.8? or 2)HR <100bpm or 3)SpO2 >95% 2.Laboratory parameters (3 of 3): 1)CRP or 2)PCT reduction 70% compared to zenith for 2 consecutive samples 3)WBC <12×10E9/L for 2 consecutive samples 3.Image parameter (1 of 1): liquid collection developed <30% compared to that of 72h

Procedure:
• oral care by chlorhexidine gluconate
oral care by 0.2% chlorhexidine gluconate twice daily
• enteral nutrition

Drug:
• Somatostatin

• Meropenem
All patients in cefo-group do not meet 1 of 3 laboratory parameter or image parameter or 2 of 3 clinical parameters. 1.Clinical parameters (2 of 3): 1)temperature<37.8? or 2)HR <100bpm or 3)SpO2 >95% 2.Laboratory parameters (3 of 3): 1)CRP or 2)PCT reduction 70% compared to zenith for 2 consecutive samples 3)WBC <12×10E9/L for 2 consecutive samples 3.Image parameter (1 of 1): liquid collection developed <30% compared to that of 72h

Locations

Country	Name	City	State
China	Depatrment of EICU,Ruijin Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Erzhen Chen	RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pancreatic or peripancreatic infection		28-day	Yes
Secondary	cost of management of SAP		90-day	No
Secondary	Microbiology resistance	sputum, urine and blood culture will be done once or twice per week if needed. bill or other culutre will be done when the patient is undergoing operation.	90-day	Yes