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

NCT ID: NCT01992198

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-12-31

Brief Summary

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

Detailed Description

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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

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Pancreatitis,Acute Necrotizing

Keywords

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antibiothearpy strategy cefoperazone metronidazole meropenem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cefoperazone + metronidazole

cefoperaozone 2g q8h + MDZ 0.5g q8h Oral care Somatostatin 3-6mg per 24h enteral nutrition

Group Type EXPERIMENTAL

oral care by chlorhexidine gluconate

Intervention Type PROCEDURE

oral care by 0.2% chlorhexidine gluconate twice daily

enteral nutrition

Intervention Type PROCEDURE

Somatostatin

Intervention Type DRUG

Meropenem

Intervention Type DRUG

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

meropenem

Meropenem 0.5g q6h or adapted with renal function. Oral care Somatostatin 3-6mg per 24h enteral nutrition

Group Type ACTIVE_COMPARATOR

cefoperazone + metronidazole

Intervention Type DRUG

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 chlorhexidine gluconate

Intervention Type PROCEDURE

oral care by 0.2% chlorhexidine gluconate twice daily

enteral nutrition

Intervention Type PROCEDURE

Somatostatin

Intervention Type DRUG

Interventions

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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

Intervention Type DRUG

oral care by chlorhexidine gluconate

oral care by 0.2% chlorhexidine gluconate twice daily

Intervention Type PROCEDURE

enteral nutrition

Intervention Type PROCEDURE

Somatostatin

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Cefobid Metronidazole chlorhexidine gluconate Enteral Nutritional Suspension(SP) by NUTRICIA somatostatin by merk

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role collaborator

Erzhen Chen

OTHER

Sponsor Role lead

Responsible Party

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Erzhen Chen

Professer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Er-Zhen Chen, M.D. & Ph.D.

Role: STUDY_CHAIR

Ruijin Hospital

En-Qiang Mao, M.D. & Ph.D.

Role: STUDY_DIRECTOR

Ruijin Hospital

Zhi-Tao Yang, M.D. & Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

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Depatrment of EICU,Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Erzhen Chen, M.D

Role: CONTACT

Phone: 86-13901753478

Enqiang Mao, M.D

Role: CONTACT

Phone: 86-13501747906

Facility Contacts

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Erzhen Chen, M.D

Role: primary

Enqiang, Mao

Role: backup

Other Identifiers

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12411950500

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SAP BUNDLE-ANTIBIOTICS

Identifier Type: -

Identifier Source: org_study_id