Mechanical Ventilation Complication Clinical Trial
Official title:
The Effect of Ulinastatin on Bronchoalveolar Lavage Fluid of Inflammatory Factors in Patients With Ventilator-associated Pneumonia
Ventilator-associated pneumonia (VAP) is an important cause of morbidity and mortality in
ventilated critically ill patients specially in intensive care unit (ICU). It is associated
with an increased duration of mechanical ventilation, high death rates and increased
healthcare costs in the development country.
Although VAP is preventable and many practices have been demonstrated to reduce the
incidence of this disease, the morbidity is still so high. VAP is hard to cure and the
mortality is about to 40% which was reported in China in 2004. If the bacteria of
multidrug-resistance(MDR) is isolated, the mortality can increase to 70%. So much more
methods should be needed in treating VAP in addition to using antibiotics.
Ulinastatin is a serine protease inhibitor with a molecular weight of 67,000 found in
healthy human urine. It is used worldwide for patients with inflammatory disorders,
including disseminated intravascular coagulation(DIC),shock, and pancreatitis . Furthermore,
ulinastatin administration can help reduce sepsis, prevent multiple organ dysfunction, and
modulate immune functions.
Actually, three studies have showed that ulinastatin treatment is associated with reduced
the levels of inflammatory factors in blood serum in patients with acute respiratory
distress syndrome(ARDS).Though analyses of serum inflammatory factors such as tumor necrosis
factor (TNF)-α and interleukin (IL)-6 have been used to determine the degree of systemic
inflammation under various clinical conditions, they can not reflect the degrees of lung
infection directly.
Basing on the results of previous studies, meta analyses and system reviews, the
investigators hypothesized that the anti-inflammatory function of ulinaststin may also
decrease the levels of inflammatory factors in bronchoalveolar lavage(BAL) fluid in Patients
with VAP.
In addition there is no prospective study to investigate the role of ulinastatin in BAL. The
investigator hopes that this study can approve the relationship between ulinastatin and
inflammatory factors in BAL. And it can improve the processes,outcomes and costs of critical
care as well.
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 .
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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