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 |
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DOI | https://doi.org/10.1186/ISRCTN52566874 |
Secondary identifying numbers | NTR745 |
- Submission date
- 22/11/2006
- Registration date
- 22/11/2006
- Last edited
- 19/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A Beishuizen
Scientific
Scientific
VU Medical Center
Department of Intensive Care
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Phone | +31(0)20 444 4444 |
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cornet@vumc.nl |
Study information
Study design | Randomised, multicentre, single-blinded, placebo controlled, parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study acronym | INFALI |
Study objectives | 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. |
Ethics approval(s) | Ethics approval received from the local medical ethics committee |
Health condition(s) or problem(s) studied | Acute lung injury, acute respiratory distress syndrome |
Intervention | 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 |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Activated Protein C (aPC) |
Primary outcome measure | 67-Gallium Pulmonary Leak Index (PLI). |
Secondary outcome measures | 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 |
Overall study start date | 01/09/2006 |
Completion date | 01/09/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 106 |
Key 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 |
Key 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 |
Date of first enrolment | 01/09/2006 |
Date of final enrolment | 01/09/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU Medical Center
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Sponsor information
Vrije University Medical Center (VUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Intensive Care
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Website | http://www.vumc.nl/english/ |
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https://ror.org/00q6h8f30 |
Funders
Funder type
Industry
Added as of 24/06/2008:
No information available
Lilly Nederland B.V. (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 14/03/2014 | Yes | No |