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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?

Pancreatitis,Acute Necrotizing

Study Interventions

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

Procedure:enteral nutrition

Drug:Somatostatin

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

Study Arms

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

Study Status

Unknown status

Start Date: July 2012

Completed Date: December 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: pancreatic or peripancreatic infection

Secondary Outcome: cost of management of SAP

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Erzhen Chen

Collaborator: RenJi Hospital

More information:https://clinicaltrials.gov/show/NCT01992198

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