NCT01992198

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

Escalade or Deseacalade Antibiotic Use in Severe Acute Pancreatitis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Erzhen Chen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Pancreatitis,Acute Necrotizing

Interventions

Type	Name	Description
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
PROCEDURE	enteral nutrition
DRUG	Somatostatin
DRUG	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

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-12-01
• Completion: 2016-12-01
• First posted: 2013-11-25
• Last updated: 2013-11-25

Locations

1 site across 1 country: China