Heparin Clinical Trial
Official title:
Efficacy of Heparin Nebulization on Lung Injury Score in Inhalation Burn Injury
This is a prospective randomized clinical trial about the efficacy of heparin nebulization on lung injury score in inhalation burn injury in Mothary burn hospital. This study would consist of 170 burn patients with documented inhalation injury in 2 arms (control group and study group). Allocation ratio is1:1. Masking was not possible. The patients' primary outcome will be assessed for Lung Injury Scale and the patients' secondary outcome will be assessed for mortality, Coagulation tests (PT, PTT), ICU and hospital stay and duration of mechanical ventilation support. Duration of this study is about 32 months.
This study would consist of 170 burn patients with documented smoke inhalation injury who
will be randomized to receive either standard care alone (control group) or standard care
plus heparin nebulization in combination with intravenously administrated fresh frozen
plasma (study group). Standard care treatment consist of: chest physiotherapy ,early
ambulation, airway suctioning, bronchial hygiene therapy , salbutamol nebulization (100-200
µgQ4h)/N-acetyl cysteine 20% nebulization (3cc Q4h) and if needed mechanical ventilation
support. Study care treatment consist of: Standard care + Heparin nebulized
administration(5000U every 4 hours for 7 days) and fresh frozen plasma intravenously
administration (10 cc/Kg daily for 7 days) The patients' primary outcome will be assessed
for Lung Injury Scale (LIS) every day by using fallowing parameters: (1) chest X-ray
evaluated for alveolar consolidation (2) ratio of the partial pressure of oxygen in arterial
blood to the inspiratory fraction of oxygen (3) PEEP level if ventilated (4) respiratory
compliance if known Parameter Finding Value Rx.Torax no alveolar consolidation 0 alveolar
consolidation de 1 quadrant 1 alveolar consolidation de 2 quadrant 2 alveolar consolidation
de 3 quadrant 3 alveolar consolidation de 4 quadrant 4 Hypoxemia PaO2/FIO2 > 300 0 PaO2/FIO2
225 - 299 1 PaO2/FIO2 175 - 224 2 PaO2/FIO2 100 - 174 3 PaO2/FIO2 < 100 4 PEEP PEEP <= 5 cm
H2O 0 PEEP 6 - 8 cm H2O 1 PEEP 9 - 11 cm H2O 2 PEEP 12 - 14 cm H2O 3 PEEP >= 15 cm H2O 4
Compliance >= 80 mL/cm H2O 0 compliance 60 - 79 mL/cm H2O 1 compliance 40 - 59 mL/cm H2O 2
compliance 20 - 39 mL/cm H2O 3 compliance <= 19 mL/cm H2O 4 2 The patients' secondary
outcome will be assessed for mortality(for 28 days post injury), Coagulation tests(PT,PTT)
(for 7 days post injury),ICU and hospital stay(for 7 days post injury) and duration of
mechanical ventilation support(for 7 days post injury). In each group 85 Patients will be
selected by simple randomization. Allocation ratio is1:1. Blinding of this study was not
possible.
PEEP: positive end expiratory pressure- PaO2: partial pressure of oxygen in arterial blood-
FIO2: inspiratory fraction of oxygen PT: prothrombin time- PTT: partial thrombin time- ICU:
intensive care unite- Rx: X-Ray
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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