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The Effect of Ulinastatin on Bronchoalveolar Lavage Fluid of Inflammatory Factors in Patients With Ventilator-associated Pneumonia


Phase 2/Phase 3
18 Years
80 Years
Not Enrolling
Both
Ventilator-associated Bacterial Pneumonia, Mechanical Ventilation Complication

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Trial Information

The Effect of Ulinastatin on Bronchoalveolar Lavage Fluid of Inflammatory Factors in Patients With Ventilator-associated Pneumonia


This is a one-center, three-arm, randomized, single-blinded, controlled trial. When a
patient was diagnosed VAP during mechanic ventilation in ICU,a sealed envelop will be opened
which decide whether the patient is assigned to the normal dose ulinastatin group,the high
dose ulinastatin group or the compare group.

VAP diagnosis and treatment accord with the "Comprehensive evidence-based clinical practice
guidelines for ventilator-associated pneumonia:Diagnosis and treatment" which was published
in 2008 by Canadian critical care trials group.

The aim of the present study is to determine the efficacy of ulinastatin for the treatment
of ventilator-associated Pneumonia(VAP) and to investigate the effect to inflammatory
factors in bronchoalveolar lavage fluid .


Inclusion Criteria:



- All consecutive patients with ventilator-associated pneumonia(VAP) who are admitted
to the intensive care unit between 1st January 2014 at 0:00(midnight) and the finish
date of 31st December 2015 at 23:59 (11:59 pm).

- Informed consent.

Exclusion Criteria:

- Patients with pneumonia when they are admitted to ICU.

- Ulinastatin was previous used before the patients were diagnosed VAP.

- Active gastropathic disorder.

- Be allergic to ulinastatin.

- Pregnancy.

- Unwilling to continue the therapy during hospitalization.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Levels of inflammatory factors in bronchoalveolar lavage fluid and blood serum.

Outcome Description:

The variety of tumor necrosis factor-α(TNF-α),interleukin-10(IL-10),interleukin-18(IL-18) and interferon-γ(INF-γ) in bronchoalveolar lavage fluid and blood serum are observed.

Outcome Time Frame:

7 days

Safety Issue:

Yes

Authority:

China: Food and Drug Administration

Study ID:

VAP-YYT-003

NCT ID:

NCT01865266

Start Date:

January 2014

Completion Date:

June 2016

Related Keywords:

  • Ventilator-associated Bacterial Pneumonia
  • Mechanical Ventilation Complication
  • ventilator-associated pneumonia
  • mechanical ventilation
  • ulinastatin for injection
  • bronchoalveolar lavage fluid
  • inflammatory factors
  • Pneumonia, Bacterial
  • Pneumonia
  • Pneumonia, Ventilator-Associated

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