Study to find an effect of ulinastatin in protecting the development of acute kidney injury induced by colistin in severe pneumonia

Not Applicable

Conditions: Certain infectious and parasitic diseases

Registration Number: KCT0005684

Lead Sponsor: Yonsei University, Wonju Severance Christian Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Adults over 20 years old
2. Patients with septic shock due to pneumonia or who are treated in the intensive care unit (if admitted to the intensive care unit, they are considered as severe pneumonia regardless of the presence or absence of a ventilator or the severity of pneumonia)
3. Infection with multidrug-resistant Acinetobacter baumannii (ABA) or Pseudomonas aeruginosa (PAE) susceptible only to colistin, confirmed in culture test of lower airway samples.

? Definition of septic shock
It is defined as septic shock if it satisfies all the criteria for ? sepsis and ? septic shock, or only meets the criteria for ? septic shock.

? Definition of sepsis
If two or more of the following four items are met;
? Body temperature >38? or <36?
? Heart rate >90/min
? Respiration rate >20/min or PaCO2 <32mmHg
? White blood cells >12,000/?or <4,000/?

? Definition of septic shock
Mean arterial pressure (MAP) <65mmHg
[MAP = (systolic blood pressure + 2 x diastolic blood pressure)/3]

? Definition of multidrug resistance
Multi-drug resistance is defined when resistance to all drugs including imipenem, except for colistin, is shown.

Exclusion Criteria

1. If ABA or PAE is confirmed in culture test, but regarded as simple colonization rather than the causative agent of pneumonia.
2. Patients currently receiving any cancer treatment including lung cancer (if patients received cancer treatment but is cured, it does not fall under the exclusion criteria.)
3. Serum creatinine (Cr) = 2.0 mg/dl

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of incidence rate of acute kidney injury

Secondary Outcome Measures

Name	Time	Method
Clinical parameters: SOFA score, APACHE II score, mortality, duration of mechanical ventilation, ICU admission days, renal function test, bacteria culture;Inflammatory parameters: serum CRP, procalcitonin, IL-6, IL-10, TNF-a