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

Protective effect of ulinastatin against colistin-induced acute kidney injury in patients with severe pneumonia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0005684

Enrollment

Registered

2020-12-21

Start date

2020-12-15

Completion date

Unknown

Last updated

2021-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Drug name: Ulinastatin (Ulistin? 100,000 IU/2mL, Hanlim Pharmaceutical) Dosage: 300,000 IU twice per day (600,000 IU/day) Duration: 7 days Route: Intravenous

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Comparison of incidence rate of acute kidney injury	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactJi-Ho Lee

Yonsei University, Wonju Severance Christian Hospital

Outcome results