Title
Multi-center Clinical Study of Early Antibios of Severe Acute Pancreatitis
Escalade or Deseacalade Antibiotic Use in Severe Acute Pancreatitis
Phase
Phase 4Lead Sponsor
Shanghai Ruijin Hospital NorthStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Pancreatitis,Acute NecrotizingIntervention/Treatment
metronidazole somatostatin cefoperazone meropenem chlorhexidine ...Study Participants
60Strategy of antibiotic therapy in SAP,De-escalate (cefoperazone+metronidazole) or Escalate (meropenem) therapy,which one is better.
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.
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
oral care by 0.2% chlorhexidine gluconate twice daily
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
cefoperaozone 2g q8h + MDZ 0.5g q8h Oral care Somatostatin 3-6mg per 24h enteral nutrition
Meropenem 0.5g q6h or adapted with renal function. Oral care Somatostatin 3-6mg per 24h enteral nutrition
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
