Pancreatitis,Acute Necrotizing | Multi-center Clinical Study of Early Antibios of Severe Acute Pancreatitis
Pancreatitis,Acute Necrotizing research study
What is the primary objective of this study?
Strategy of antibiotic therapy in SAP,De-escalate (cefoperazone+metronidazole) or Escalate (meropenem) therapy,which one is better.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:cefoperazone + metronidazole1.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 gluconateoral care by 0.2% chlorhexidine gluconate twice daily
Drug:MeropenemAll 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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
cefoperazone + metronidazolecefoperaozone 2g q8h + MDZ 0.5g q8h Oral care Somatostatin 3-6mg per 24h enteral nutrition
meropenemMeropenem 0.5g q6h or adapted with renal function. Oral care Somatostatin 3-6mg per 24h enteral nutrition
Start Date: July 2012
Completed Date: December 2016
Phase: Phase 4
Primary Outcome: pancreatic or peripancreatic infection
Secondary Outcome: cost of management of SAP
Study sponsors, principal investigator, and references
Lead Sponsor: Erzhen Chen
Collaborator: RenJi Hospital