Pneumonia-induced acute respiratory distress syndrome (ARDS) complicated with disseminated intravascular coagulation(DIC) and sepsis, including avian influenza virus infection
Conditions
Interventions
Drip infusion of 380 U/kg of rTM q24 hours for maximum 6 days.
Sponsors
National Hospital for Pediatrics, Nanoi, Vietnam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Severe ARDS complicated with DIC and sepsis. Patients who fulfill all of the followings (1-5) within 72 hours from PICU admission 1) The patients who admitted the PICU-NHP 2) Age: 1 month -15 years old 3) DIC score is within ISTH DIC criteria (Score 5 or more). 4) PaO2/FiO2 ratio (P/F ratio) less than 100 mmHg in arterial blood gas analysis. 5) No severe left ventricular dysfunction 6) Chest X ray abnormal shadow (consolidation, ground-glass opacity, or nodular shadow) 7) Patients provide written informed consent prior to initiation of any study procedures. Patients who or whose attorney are able to understand and comply with planned study procedures. 2.Avian influenza virus infection induced ARDS complicated with DIC and sepsis. Patients who fulfill all of the followings (1-9) within 72 hours from PICU admission 1) Contact with sick or dead poultry 2) Positive result of rapid diagnostic test for influenza A, or avian influenza viral genomes are positive with PCR. 3) Patients with 2 or more of the following symptoms. Fever, Cough, Dyspnea, Sore throat, Nasal congestion or rhinorrhea, Headache, Myalgia or arthralgia 4) The patients who admitted the PICU-NHP 5) Age: 1 month -15 years old 6) DIC score is within ISTH DIC criteria (Score more more than 5) 7) PaO2/FiO2 ratio (P/F ratio) less than 300 mmHg in arterial blood gas analysis 8) Chest X ray abnormal shadow (consolidation, ground-glass opacity, or nodular shadow) 9) Patients provide written informed consent prior to initiation of any study procedures. Patients who or whose attorney are able to understand and comply with planned study procedures.
Exclusion criteria
Exclusion criteria: Patients who fulfill any of the followings are excluded 1. Patients with severe renal dysfunction (creatinine clearance < 10mL/min) 2. Patients with bleeding symptoms. 3. Patients whom the treating doctor deems, for any reason, to be ineligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of plasma thrombomodullin concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Observation of clinical course 1.1. Status of DIC (1) DIC score(ISTH) (2) Bleeding symptoms (3) Vital signs and physical examination findings (4) Other laboratory findings; e.g. proinflammatory cytokines 1.2. Status of ARDS (1) P/F ratio (2) Duration of fever (3) Duration of mechanical ventilation including CPAP (4) Vital signs, physical examination findings and SpO2 (5) Chest X ray findings Extent of infiltration: 0=No infiltration, 1=Unilateral, 2=bilateral (6) Other laboratory findings; e.g. blood gas analysis 1.3. The change of liver function and renal function 2. Outcome 3. The etiology of pneumonia-induced ARDS complicated with DIC and sepsis | — |
Countries
Asia(except Japan)
Contacts
Public ContactJin Takasaki
National Center for Global Health and Medicine Department of respiratory medicine
Outcome results
None listed