Activated protein C versus placebo in the treatment of INFlammatory or infectious Acute Lung Injury/acute respiratory distress syndrome (INFALI): a pathophysiological study on pulmonary microvascular permeability, apoptosis, inflammation and coagulatio

Completed

• Conditions: Acute lung injury, acute respiratory distress syndrome; Respiratory; Other respiratory disorders

• Registration Number: ISRCTN52566874
• Lead Sponsor: Vrije University Medical Center (VUMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 106

Inclusion Criteria

1. Age 18 to 75 years
2. Weight less than 135 kg
3. Recent onset (less than 24 hours) of ALI/ARDS, according to the American/European consensus criteria
4. ALI/ARDS due to severe sepsis reflecting single organ failure

Exclusion Criteria

1. Acute Physiology And Chronic Health Evaluation (APACHE II) score: 25 and more
2. Two or more failing organs
3. Thrombocyte count less than 30 x 10^9/l
4. Any major surgery within 12 hours before inclusion
5. Trauma patients at increased risk of bleeding
6. Acute bleeding
7. A history of severe head trauma that required hospitalisation, intracranial surgery, or stroke within three months of study entry
8. Known intracranial abnormality such as aneurysms, tumor, arterio-venous malformation
9. Known hypercoagulability:
9.1. Resistance to protein C
9.2. Hereditary deficiency of protein C, protein S, or anti-thrombin
9.3. Presence of anticardiolipin antibody, antiphospholipid antibody, lupus anticoagulant or homocystinaemia
9.4. Recently documented (within three months of study entry) or highly suspected deep vein thrombosis or pulmonary embolism
10. A history of congenital bleeding diasthesis
11. Expected life expectancy less than 28 days (moribund state)
12. Preterminal illness
13. Pregnancy or breast feeding
14. Known portal hypertension with liver cirrhosis, oesophageal varices or both
15. Epidural catheter
16. Body weight more than 135 kg
17. Chronic renal insufficiency
18. Participation in another clinical trial
19. Patients with immune system impairment:
19.1. Human immunodeficiency virus (HIV)-infected patients (CD4+ less than 50/ml)
19.2. After bone-marrow, lung, liver, pancreas or small-bowel transplantation and treated with immunosuppressive therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
67-Gallium Pulmonary Leak Index (PLI).

Secondary Outcome Measures

Name	Time	Method
1. Lung injury score<br>2. Inflammatory mediators/biomarkers (blood, mini-BAL)<br>3. Coagulation and fibrinolysis markers (blood, mini-BAL)<br>4. Apoptosis markers (blood, mini-BAL)<br>5. Mortality<br>6. Extra-vascular lung water<br>7. Gas exchange (compliance, partial pressure of oxygen in arterial blood [PaO2]/fraction of inspired oxygen [FiO2])<br>8. Radiographic abnormalities (X-ray, CT)<br>9. Change of ventilatory mode (non-invasive versus invasive)<br>10. Duration of mechanical ventilation