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

Deaths Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040350
• Other study ID #: U1111-1151-9883
• Status: Completed
• Phase: Phase 1
• First received: January 9, 2014
• Last updated: January 16, 2014
• Start date: April 2012
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Sheri Kashmir Institute of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deaths
• Organophosphate Poisoning
• Poisoning

Intervention

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

Locations

Country	Name	City	State
India	Sheri kashmir insititute of medical sciences	Srinagar	Srinagar Kashmir

Sponsors (1)

Lead Sponsor	Collaborator
Sheri Kashmir Institute of Medical Sciences

Country where clinical trial is conducted

India, 

References & Publications (1)

Eddleston M, Buckley NA, Eyer P, Dawson AH. Management of acute organophosphorus pesticide poisoning. Lancet. 2008 Feb 16;371(9612):597-607. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	duration of ICU stay		upto one year	No
Primary	mortality rate		upto one year	No
Secondary	duration of ventilation		upto one year	No