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

January 16, 2014 updated by: Tariq Wani, Sheri Kashmir Institute of Medical Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Srinagar Kashmir
      • Srinagar, Srinagar Kashmir, India, 190006
        • Sheri kashmir insititute of medical sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Oximes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mortality rate
Time Frame: upto one year
upto one year

Secondary Outcome Measures

Outcome Measure
Time Frame
duration of ventilation
Time Frame: upto one year
upto one year

Other Outcome Measures

Outcome Measure
Time Frame
duration of ICU stay
Time Frame: upto one year
upto one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheri Kashmir Institute of Medical Sciences

Investigators

  • Study Director: Showkat Gurcoo, MD, SKIMS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 16, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Estimate)

January 20, 2014

Last Update Submitted That Met QC Criteria

January 16, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1151-9883

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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