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Activated Protein C versus placebo in the treatment of Inflammatory or Infectious ALI/ARDS (INFALI): a pathophysiological study on pulmonary microvascular permeability, apoptosis, inflammation and coagulation.

Activated Protein C versus placebo in the treatment of Inflammatory or Infectious ALI/ARDS (INFALI): a pathophysiological study on pulmonary microvascular permeability, apoptosis, inflammation and coagulation.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21017
Enrollment
106
Registered
2006-08-01
Start date
2006-09-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Acute Lung Injury (ALI), Acute Respiratory Distress Syndrome (ARDS)

Interventions

After stratification patients will be randomly assigned to the aPC (24 mcg/kg/hr during (in total) 96 hrs) or placebo group. 1. On day 1 and 5 a 67-Ga Pulmonary Leak Index and a CT-Thorax will be per

Sponsors

VU University Medical Center (VUmc), department of Intensive Care
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. age 18 - 75 years 2. weight < 135 kg 3. recent onset (<24 h) of ALI/ARDS, according to the American/European consensus criteria 4. ALI/ARDS due to severe sepsis reflecting single organ failure

Exclusion criteria

Exclusion criteria: 1. APACHE II score: 25 and more 2. 2 or more failing organs 3. thrombocytecount 135 kg 17. Chronic renal insufficiency 18. Participation in another clinical trial 19. Patients with immune system impairment 19.1 HIV-infected patients (CD4+ < 50/ml) 19.2 After bone-marrow, lung, liver, pancreas or small-bowel transplantation and treated with immunosuppressive therapy

Design outcomes

Primary

MeasureTime frame
67-Gallium pulmonary leak index (PLI)—

Secondary

MeasureTime frame
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, PaO2/FiO2) 8. radiographic abnormalities (X-ray, CT) 9. change of ventilatory mode (noninvasive vs. invasive) 10. duration of mechanical ventilation—

Contacts

Public ContactA. Beishuizen

VU Medical Center Department of Intensive Care P.O. Box 7057

beishuizen@vumc.nl+31(0)20 444444492

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)