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

NCT01992198 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-11-25

No results posted yet for this study

Summary

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

Conditions

  • Pancreatitis,Acute Necrotizing

Interventions

DRUG

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

PROCEDURE

oral care by chlorhexidine gluconate

oral care by 0.2% chlorhexidine gluconate twice daily

PROCEDURE

enteral nutrition

DRUG

Somatostatin

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

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • Erzhen Chen

    lead OTHER

Principal Investigators

  • Er-Zhen Chen, M.D. & Ph.D. · Ruijin Hospital

  • En-Qiang Mao, M.D. & Ph.D. · Ruijin Hospital

  • Zhi-Tao Yang, M.D. & Ph.D. · Ruijin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-12-31
Completion
2016-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01992198 on ClinicalTrials.gov