Pancreatitis,Acute Necrotizing
Conditions
Keywords
antibiothearpy strategy, cefoperazone, metronidazole, meropenem
Brief 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.
Interventions
DRUGcefoperazone + 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
PROCEDUREoral care by chlorhexidine gluconate
oral care by 0.2% chlorhexidine gluconate twice daily
PROCEDUREenteral nutrition
DRUGSomatostatin
DRUGMeropenem
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
Sponsors
RenJi Hospital
Erzhen Chen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pancreatic or peripancreatic infection | 28-day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cost of management of SAP | 90-day | — |
| Microbiology resistance | 90-day | 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. |
Countries
China
Contacts
Primary ContactErzhen Chen, M.D
Backup ContactEnqiang Mao, M.D
Outcome results
None listed