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Is the WHO Recommended Dose of Pralidoxime Effective in the Treatment of Organophosphorus Poisoning?

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ClinicalTrials.gov Identifier: NCT02040350
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : January 20, 2014
Sponsor:
Information provided by (Responsible Party):
Tariq Wani, Sheri Kashmir Institute of Medical Sciences

Brief Summary:
To evaluate the effectiveness of Pralidoxime, a drug used for treatment of pesticide poisoning (Organophosphorous poisonings)

Condition or disease Intervention/treatment Phase
Deaths Drug: Pralidoxime Phase 1

Detailed Description:
The present study was designed to critically analyze the role of pralidoxime in patients with moderate to severe poisoning by dividing them into two comparable groups in all aspects and using WHO recommended dose of pralidoxime (30mg/kg bolus I.V over 20 min followed by 8mg/kg/hr continuous infusion). This dose and continuous infusion protocol is more likely to maintain adequate blood concentrations of pralidoxime throughout 24 hours and thus would avoid any failures in effectiveness of pralidoxime because of inconsistent blood levels.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study Effect of WHO Recommended Dose of Pralidoxime in the Treatment of Organophosphorus Poisoning
Study Start Date : April 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Poisoning

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo was given to compare the effects
Drug: Pralidoxime
Pralidoxime was compared to placebo to study the effects of the drug on mortatlity
Other Name: Oximes

Active Comparator: Pralidoxime
Pralidoxime for treating organophosphorous poisoning patients
Drug: Pralidoxime
Pralidoxime was compared to placebo to study the effects of the drug on mortatlity
Other Name: Oximes




Primary Outcome Measures :
  1. mortality rate [ Time Frame: upto one year ]

Secondary Outcome Measures :
  1. duration of ventilation [ Time Frame: upto one year ]

Other Outcome Measures:
  1. duration of ICU stay [ Time Frame: upto one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

history of alleged organophosphorus intake age > 14 years < 60 years clinical signs and symptoms of organophosphorus poisoning.

Exclusion Criteria:

< 14 years or > 60 years of age known pregnancy pralidoxime administration at the transferring hospital carbamate poisoning any chronic illnesses

≥ 12 hour interval from time of poisoning to initiation of treatment pre-hospital cardiac or respiratory arrest.


Information from the National Library of Medicine

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): NCT02040350


Locations
India
Sheri kashmir insititute of medical sciences
Srinagar, Srinagar Kashmir, India, 190006
Sponsors and Collaborators
Sheri Kashmir Institute of Medical Sciences
Investigators
Study Director: Showkat Gurcoo, MD SKIMS

Publications:
Responsible Party: Tariq Wani, Registar, Sheri Kashmir Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT02040350     History of Changes
Other Study ID Numbers: U1111-1151-9883
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: January 20, 2014
Last Verified: January 2014

Keywords provided by Tariq Wani, Sheri Kashmir Institute of Medical Sciences:
Pralidoxime, atropine, organophosphorous poisoning.

Additional relevant MeSH terms:
Poisoning
Organophosphate Poisoning
Chemically-Induced Disorders
Pralidoxime
Antidotes
Protective Agents
Physiological Effects of Drugs
Cholinesterase Reactivators
Enzyme Reactivators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents