None listed
Conditions
Brief summary
Patients who are in intensive care may need to have their breathing assisted by a ventilator. Although all care is taken,pneumonia develops in 12% of patients on ventilators. This is because tubes connecting patients to the ventilator impair the lungs normal defenses against infection and causes inflammation in the airways. Inhaled heparin may assist to reduce this risk. Heparin has been used in patients with airway burns and has shown to decrease the inlammation and promote healing. This study will attempt to determine if giving inhaled heparin to patients needing mechanical ventilation will reduce their chances of developing pneumonial
Interventions
ARM 1:(a) Intervention group - nebulised unfractionated sodium heparin ( 2 mls, 5000 U) every 6 hours
ARM 2:(b) Placebo group 1 (2 mls of Sodium Chloride0.9%) every 6 hours or usual practice of nebulised bronchodilators for clinical indication only
ARM 3:(c) Placebo group 2 Usual care-unblinded– no active nebulized treatment with saline unless deemed clinically necessary by the treating clinician
In both arm 1 and 2 the patients will receive the study drug until the patient has been extubated
ARM 1:(a) Intervention group - nebulised unfractionated sodium heparin ( 2 mls, 5000 U) every 6 hours ARM 2:(b) Placebo group 1 (2 mls of Sodium Chloride0.9%) every 6 hours or usual practice of nebulised bronchodilators for clinical indication only ARM 3:(c) Placebo group 2 Usual care-unblinded– no active nebulized treatment with saline unless deemed clinically necessary by the treating clinician In both arm 1 and 2 the patients will receive the study drug until the patient has been extubated for more than 48 hrs and the clinician is confident that the patient is pneumonia free and reintubation is unlikely or if the patient is extubated and discharged within the 48hrs.
Sponsors
A/Prof Robert Boots
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Non-invasively mechanically ventilated for < 24hours prior to intubation No previous mechanical ventilation
Exclusion criteria
1.Pregancy 2.Aged less than 18 years of age 3.Patients with previous known sensitivity to heparin (any formulation or route) including heparin induced thrombocytopenia 4.Any contraindication to routine prophylaxis for deep vein thrombosis using subcutaneous heparin 5.Presence of a coagulopathy including platelet dysfunction thought to be of clinical significance of any type on admission considered to be a contraindication to routine prophylaxis for deep vein thrombosis using subcutaneous heparin 6.Patients receiving any other type of systemic full anticoagulation 7.Patients transferred from another intensive care unit with more than 48 hours of mechanical ventilation before entering into the present study. Patients receiving routine subcutaneous thromboembolism prophylaxis (= 15,000/units day) or heparin as part of continuous dialysis therapy where systemic anticoagulation is not required are suitable for inclusion but enrolled patients must be withdrawn from the study upon the need for systemic full anticoagulation or bleeding considered due to the effects of the inhaled heparin by the treating consultant.
Outcome results
None listed