Adding Nebulized Salbutamol to Intravenous Atropine and Oxygen in OP Poisoning (SalbutamolOP)
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|ClinicalTrials.gov Identifier: NCT02160548|
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : December 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Organophosphate Poisoning||Drug: Standard care Drug: Standard care+ 2.5 mg Salbutamol Drug: Standard care+ 5 mg Salbutamol||Phase 3|
Pesticide self-poisoning kills over 300,000 people every year (1). Most deaths occur in rural Asia where widespread use of pesticides to boost food production allows easy access at stressful times. The WHO now recognizes pesticide poisoning to be the single most important global means of suicide (2) Amongst pesticides, organophosphorus (OP) and carbamate insecticides are of most concern, causing about 2/3 of deaths (1,3). These insecticides inhibit the enzyme acetylcholinesterase (AChE), producing an 'acute cholinergic crisis' with reduced consciousness, bradycardia, hypotension, and acute respiratory failure. On arrival at hospital, patients are resuscitated with atropine and, for OPs, an oxime AChE reactivator (4). Unfortunately, this treatment is often inadequate and many still die (5). A recent Bangladeshi RCT showed that rapid resuscitation of patients with atropine saves lives (6). This study compared a faster 'doubling dose' method of atropinisation with a standard bolus method during resuscitation. It reported quicker stabilisation and a 14% absolute reduction in mortality.
Rationale: Atropine only stops production of fluid and does not speed its removal from the lung. Therefore a treatment that increases removal, to complement atropine-induced cessation of production, could reduce fluid in the lungs and speed return effective oxygen exchange. A single nebulised dose of the beta-adrenergic agonist salbutamol may increase removal since it increases alveolar fluid removal via the epithelial sodium channel. A pilot clinical study is required to test the hypothesis and to provide data for powering a large phase III RCT.
Research question: Will addition of the beta-adrenergic agonist salbutamol to atropine during resuscitation improve oxygenation, reduce the need for atropine, and speed stabilisation?
Objectives:General Objectives: To test the efficacy of salbutamol at increasing oxygenation and speeding resuscitation.
Specific Objectives: To test whether salbutamol alters dose of atropine administered and incidence of tachydysrhythmias.
Total duration of the study will be one year and all patients aged 12 years or older with clinical features of OP/carbamate poisoning requiring oxygen and atropine will be enrolled. The study will be done in three arms.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Adding Nebulized Salbutamol to Intravenous Atropine and Oxygen During Resuscitation of OP Pesticide Poisoned Patients|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Placebo Comparator: 'Standard care'
Standard care= Intravenous fluids, Oxygen by face mask, Intubation if necessary, Mechanical ventilation (Engstrom Pro by GE) if necessary, Cardiac monitor (Infunix IP4050), Atropine (anti-muscarinic drug; G-Atropine) by intravenous route, Pralidoxime (acetylcholinesterase reactivating oxime drug; PAM-A) by intravenous route.
Drug: Standard care
Standard management for OP poisoning
Experimental: 'Standard care+ 2.5 mg Salbutamol'
Standard care+ 2.5 mg Salbutamol= Nebulized salbutamol (Ventolin respiratory solution) 2.5 mg stat and once only with standard care
Drug: Standard care+ 2.5 mg Salbutamol
Ventolin respiratory solution 2.5 mg
Other Name: Ventolin
Experimental: 'Standard care+ 5 mg Salbutamol'
Standard care+ 5 mg Salbutamol= Nebulized salbutamol (Ventolin respiratory solution) 5 mg stat and once only with standard care
Drug: Standard care+ 5 mg Salbutamol
Ventolin respiratory solution 5 mg
Other Name: Ventolin
- Improvement of oxygen saturation [ Time Frame: 60 minutes ]Improvement of oxygen saturation from the base line to normal level after adding nebulized salbutamol to regular I/V atropine and oxygen therapy.
- Heart rate, respiratory rate and Blood pressure [ Time Frame: 60 minutes ]Settlement of heart rate, respiratory rate and blood pressure to normal range after adding salbutamol to regular management.
- Atropine dose [ Time Frame: 120 minutes ]Requirement of total atropine dose until full atropinization (before put in to maintenance dose) after adding nebulized salbutamol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160548
|Sylhet M.A.G.Osmani Medical College Hospital|
|Sylhet, Bangladesh, 3100|
|Principal Investigator:||Fazle R Chowdhury, FCPS||Consultant, Medicine, Sylhet M.A.G.Osmani Medical Collge, Sylhet, Bangladesh|
|Principal Investigator:||Michael Eddleston, PhD||Professor of Clinical Toxicology, University of Edinburgh|