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

NCT01865266 | Unknown Phase 2 DMC

• 1 other identifier: VAP-YYT-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventilator-associated Bacterial Pneumonia; Mechanical Ventilation Complication

Keywords

ventilator-associated pneumonia; mechanical ventilation; ulinastatin for injection; bronchoalveolar lavage fluid; inflammatory factors

Outcome Measures

Primary Outcomes (1)

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

  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.

  7 days

Secondary Outcomes (5)

• All cause mortality.

  30 days

• Ventilation free days.

  30 days

• Antibiotic free days.

  30 days

• Percentage of MDR pathogenic bacteria.

  30 days

• Oxygenation index

  30 days

Other Outcomes (1)

• Adverse effects

  30 days

Study Arms (3)

NUTIG

EXPERIMENTAL

The normal dose of ulinastatin for injection group(NUTIG): Ulinastatin(Techpool inc,Guangdong,China) was administered to the group as a bolus of 100,000 U diluted in 100 mL of normal saline every 8 hour.A course of treatment consisted of 7 days after the patients were diagnosed as VAP.

Drug: Ulinaststin for injection

HUTIG

EXPERIMENTAL

The high dose of ulinastatin for injection group(HUTIG): Ulinastatin(Techpool inc,Guangdong,China) was administered to the group as a bolus of 200,000 U diluted in 100 mL of normal saline every 8 hour.A course of treatment consisted of 7 days after the patients were diagnosed as VAP.

Drug: Ulinaststin for injection

CG

PLACEBO COMPARATOR

The compare group(CG): The group was given 100 mL of normal saline every 8 hour.A course of treatment consisted of 7 days after the patients were diagnosed as VAP.

Drug: placebo

Interventions

Ulinaststin for injection DRUG

HUTIG; NUTIG

placebo DRUG

CG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Minhang Central Hospital: lead
• Ruijin Hospital: collaborator
• RenJi Hospital: collaborator
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Shanghai Minhang Central Hospital

Shanghai, 201199, China

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Injections

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Yu YueTian, MD

CONTACT

13818227011; fishyyt@sina.com

Liu ChunYan, MD

CONTACT

13917836226; doctorlcy@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shanghai Minhang Central Hospital

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: May 30, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: May 30, 2013

Record last verified: 2013-05

Locations

CN (1)