Adding Nebulized Salbutamol to Intravenous Atropine and Oxygen in OP Poisoning

NCT02160548 | Completed Phase 3 DMC

• 1 other identifier: Medicine SOMCH
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that salbutamol will speed removal of alveolar fluid compared to atropine alone in OP poisoned patients. We propose to compare the effect of two stat doses of nebulized salbutamol (2.5 mg; 5.0 mg), with nebulized saline placebo, in symptomatic patients receiving standard resuscitation with atropine, oxygen, and fluids after poisoning with OP pesticides. 25 patients will be randomised to each arm (total 75 patients). Primary outcome will be oxygen saturation's over the following 60 min during resuscitation. Secondary outcomes will include atropine dose administered, speed to stabilization, aspiration or pneumonia, intubation, tachydysrhythmias, and mortality. A positive outcome will result in design of a large definitive phase III study.

Conditions

Organophosphate Poisoning

Keywords

Organophosphate, insectiside, Salbutamol, Atropine

Outcome Measures

Primary Outcomes (1)

• Improvement of oxygen saturation

  Improvement of oxygen saturation from the base line to normal level after adding nebulized salbutamol to regular I/V atropine and oxygen therapy.

  60 minutes

Secondary Outcomes (1)

• Heart rate, respiratory rate and Blood pressure

  60 minutes

Other Outcomes (1)

• Atropine dose

  120 minutes

Study Arms (3)

'Standard care'

PLACEBO COMPARATOR

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 care+ 2.5 mg Salbutamol'

EXPERIMENTAL

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

'Standard care+ 5 mg Salbutamol'

EXPERIMENTAL

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

Interventions

Standard care DRUG

Standard management for OP poisoning

Also known as: Intravenous fluids, Intubation if necessary,, Mechanical ventilation if necessary (Engstrom Pro), Atropine (anti-muscarinic; G-Atropine), Pralidoxime (acetylcholinesterase reactivating oxime; PAM-A), Oxygen by face mask by intravenous route,

'Standard care'

Standard care+ 2.5 mg Salbutamol DRUG

Ventolin respiratory solution 2.5 mg

Also known as: Ventolin

'Standard care+ 2.5 mg Salbutamol'

Standard care+ 5 mg Salbutamol DRUG

Ventolin respiratory solution 5 mg

Also known as: Ventolin

'Standard care+ 5 mg Salbutamol'

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age 12 yrs or older
• clinical features of OP poisoning
• requiring oxygen and atropine and give consent

You may not qualify if:

• age 11 yrs or younger
• no requirement for atropine

Sponsors & Collaborators

• Sylhet M.A.G.Osmani Medical College: lead
• University of Edinburgh: collaborator

Study Sites (1)

Sylhet M.A.G.Osmani Medical College Hospital

Sylhet, Sylhet Division, 3100, Bangladesh

Location

Related Publications (4)

• Abedin MJ, Sayeed AA, Basher A, Maude RJ, Hoque G, Faiz MA. Open-label randomized clinical trial of atropine bolus injection versus incremental boluses plus infusion for organophosphate poisoning in Bangladesh. J Med Toxicol. 2012 Jun;8(2):108-17. doi: 10.1007/s13181-012-0214-6.

  PMID: 22351300 BACKGROUND

• Eddleston M, Buckley NA, Eyer P, Dawson AH. Management of acute organophosphorus pesticide poisoning. Lancet. 2008 Feb 16;371(9612):597-607. doi: 10.1016/S0140-6736(07)61202-1.

  PMID: 17706760 BACKGROUND

• Gunnell D, Eddleston M, Phillips MR, Konradsen F. The global distribution of fatal pesticide self-poisoning: systematic review. BMC Public Health. 2007 Dec 21;7:357. doi: 10.1186/1471-2458-7-357.

  PMID: 18154668 BACKGROUND

• Eddleston M. Patterns and problems of deliberate self-poisoning in the developing world. QJM. 2000 Nov;93(11):715-31. doi: 10.1093/qjmed/93.11.715.

  PMID: 11077028 BACKGROUND

MeSH Terms

Conditions

Organophosphate Poisoning

Interventions

Standard of Care; Atropine; pralidoxime; Albuterol

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Medicine

Study Record Dates

• First Submitted: June 7, 2014
• First Posted: June 10, 2014
• Study Start: April 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

BA (1)