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Completed

NCT Number: NCT02040350

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

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

Completed

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Key information

Conditions

Deaths Death Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

14 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sheri kashmir insititute of medical sciences

Srinagar, Srinagar Kashmir, 190006, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pralidoxime

Drug

Pralidoxime was compared to placebo to study the effects of the drug on mortatlity

Other names: Oximes

Primary outcomes

  1. mortality rate

    Time frame: upto one year

Secondary outcomes

  1. duration of ventilation

    Time frame: upto one year

Other outcomes

  1. duration of ICU stay

    Time frame: upto one year

Sponsors and collaborators

Lead sponsor

Sheri Kashmir Institute of Medical Sciences

Other

Registry information

Official study title

Study Effect of WHO Recommended Dose of Pralidoxime in the Treatment of Organophosphorus Poisoning

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 20, 2014
Registry last updated
Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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