Hiran Bandeshe1, Rob Boots2, Joel Dulhunty1, Rachael Dunlop1, Anthony Holley1, Paul Jarrett1, Charles D Gomersall3, Jeff Lipman1, Thomas Lo3, Steven O'Donoghue1, Jenny Paratz4, David Paterson1, Jason A Roberts1, Therese Starr1, Di Stephens5, Janine Stuart1, Jane Thomas5, Andrew Udy6, Hayden White7. 1. Department of Intensive Care Medicine, Royal Brisbane & Women's Hospital, Brisbane, QLD, Australia; Burns Trauma and Critical Care Research Centre, University of Queensland, QLD, Australia. 2. Department of Intensive Care Medicine, Royal Brisbane & Women's Hospital, Brisbane, QLD, Australia; Burns Trauma and Critical Care Research Centre, University of Queensland, QLD, Australia. Electronic address: r.boots@uq.edu.au. 3. Prince of Wales Hospital, Chinese University of Hong Kong, Sha Tin, Hong Kong. 4. Department of Intensive Care Medicine, Royal Brisbane & Women's Hospital, Brisbane, QLD, Australia; Burns Trauma and Critical Care Research Centre, University of Queensland, QLD, Australia; Heart Foundation Research Centre, Griffith University. 5. Intensive Care Unit. Royal Darwin Hospital, NT, Australia. 6. Department of Intensive Care and Hyperbaric Medicine, The Alfred, Prahran, Victoria, Australia. 7. Intensive Care Unit. Logan Hospital, Queensland, Australia.
Abstract
PURPOSE: To determine whether prophylactic inhaled heparin is effective for the prevention and treatment of pneumonia patients receiving mechanical ventilation (MV) in the intensive care unit. METHODS: A phase 2, double blind randomized controlled trial stratified for study center and patient type (non-operative, post-operative) was conducted in three university-affiliated intensive care units. Patients aged ≥18years and requiring invasive MV for more than 48hours were randomized to usual care, nebulization of unfractionated sodium heparin (5000 units in 2mL) or placebo nebulization with 0.9% sodium chloride (2mL) four times daily with the main outcome measures of the development of ventilator associated pneumonia (VAP), ventilator associated complication (VAC) and sequential organ failure assessment scores in patients with pneumonia on admission or who developed VAP. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12612000038897. RESULTS:Two hundred and fourteen patients were enrolled (72 usual care, 71 inhaledsodium heparin, 71 inhaled sodium chloride). There were no differences between treatment groups in terms of the development of VAP, using either Klompas criteria (6-7%, P=1.00) or clinical diagnosis (24-26%, P=0.85). There was no difference in the clinical consistency (P=0.70), number (P=0.28) or the total volume of secretions per day (P=.54). The presence of blood in secretions was significantly less in the usual care group (P=0.005). CONCLUSION:Nebulized heparin cannot be recommended for prophylaxis against VAP or to hasten recovery from pneumonia in patients receiving MV.
RCT Entities:
PURPOSE: To determine whether prophylactic inhaled heparin is effective for the prevention and treatment of pneumoniapatients receiving mechanical ventilation (MV) in the intensive care unit. METHODS: A phase 2, double blind randomized controlled trial stratified for study center and patient type (non-operative, post-operative) was conducted in three university-affiliated intensive care units. Patients aged ≥18years and requiring invasive MV for more than 48hours were randomized to usual care, nebulization of unfractionated sodium heparin (5000 units in 2mL) or placebo nebulization with 0.9% sodium chloride (2mL) four times daily with the main outcome measures of the development of ventilator associated pneumonia (VAP), ventilator associated complication (VAC) and sequential organ failure assessment scores in patients with pneumonia on admission or who developed VAP. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12612000038897. RESULTS: Two hundred and fourteen patients were enrolled (72 usual care, 71 inhaled sodium heparin, 71 inhaled sodium chloride). There were no differences between treatment groups in terms of the development of VAP, using either Klompas criteria (6-7%, P=1.00) or clinical diagnosis (24-26%, P=0.85). There was no difference in the clinical consistency (P=0.70), number (P=0.28) or the total volume of secretions per day (P=.54). The presence of blood in secretions was significantly less in the usual care group (P=0.005). CONCLUSION: Nebulized heparin cannot be recommended for prophylaxis against VAP or to hasten recovery from pneumonia in patients receiving MV.
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