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| [ ...Back to search results ] | [ Print-friendly version ] |
| 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 coagulation |
| ISRCTN | ISRCTN52566874 |
| ClinicalTrials.gov identifier | |
| Public title | 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 coagulation |
| Scientific title | |
| Acronym | INFALI |
| Serial number at source | NTR745 |
| Study hypothesis |
We hypothesise that systemic activated Protein C (aPC) will benefit patients with Acute Lung Injury (ALI)/ Acute Respiratory Distress Syndrome (ARDS), as caused by inflammatory as well as infectious disorders, in terms of gas exchange, edema and capillary leak in these lungs, as well as in ventilator-days (duration of mechanical ventilation) or change in ventilatory mode.
Please note that as of 24/06/2008 more details on the sources of funding have been added to this record (i.e., funding now confirmed). This can be seen below in the sources of funding section. |
| Lay summary | |
| Ethics approval | Ethics approval received from the local medical ethics committee |
| Study design | Randomised, multicentre, single-blinded, placebo controlled, parallel group trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Acute lung injury, acute respiratory distress syndrome |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/09/2006 |
| Anticipated end date | 01/09/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 106 |
| Interventions |
After stratification patients will be randomly assigned to the aPC (24 mcg/kg/hr during [in total] 96 hours) or placebo group.
1. On day one and five a 67-Ga pulmonary leak index and a computed tomography (CT)-thorax will be performed 2. In mechanically ventilated patients: mini-broncho alveloar lavage (mini-BAL) every second day 3. Day one to five, seven, nine, 11, 13, 15 blood samples and a chest X-ray |
| Primary outcome measure(s) | 67-Gallium Pulmonary Leak Index (PLI). |
| Secondary outcome measure(s) |
1. Lung injury score
2. Inflammatory mediators/biomarkers (blood, mini-BAL) 3. Coagulation and fibrinolysis markers (blood, mini-BAL) 4. Apoptosis markers (blood, mini-BAL) 5. Mortality 6. Extra-vascular lung water 7. Gas exchange (compliance, partial pressure of oxygen in arterial blood [PaO2]/fraction of inspired oxygen [FiO2]) 8. Radiographic abnormalities (X-ray, CT) 9. Change of ventilatory mode (non-invasive versus invasive) 10. Duration of mechanical ventilation |
| Sources of funding |
Added as of 24/06/2008:
Lilly Nederland B.V. (The Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Dr A Beishuizen |
| Address |
VU Medical Center
Department of Intensive Care P.O. Box 7057 |
| City/town | Amsterdam |
| Zip/Postcode | 1007 MB |
| Country | Netherlands |
| Tel | +31(0)20 444 4444 |
| cornet@vumc.nl | |
| Sponsor | Vrije University Medical Center (VUMC) (The Netherlands) |
| Address |
Department of Intensive Care
P.O. Box 7057 |
| City/town | Amsterdam |
| Zip/Postcode | 1007 MB |
| Country | Netherlands |
| Sponsor website: | http://www.vumc.nl/english/ |
| Date applied | 22/11/2006 |
| Last edited | 24/06/2008 |
| Date ISRCTN assigned | 22/11/2006 |
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