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

Primary Purpose

Deaths

Status

Completed

Phase

Phase 1

Locations

India

Study Type

Interventional

Intervention

Pralidoxime

Sponsored by

Sheri Kashmir Institute of Medical Sciences

About this trial

This is an interventional treatment trial for Deaths focused on measuring Pralidoxime, atropine, organophosphorous poisoning.

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sheri kashmir insititute of medical sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Pralidoxime

Arm Description

Placebo was given to compare the effects

Pralidoxime for treating organophosphorous poisoning patients

Outcomes

Primary Outcome Measures

mortality rate

Secondary Outcome Measures

duration of ventilation

Full Information

NCT ID

First Posted

January 9, 2014

Last Updated

January 16, 2014

Sponsor

Sheri Kashmir Institute of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02040350

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sheri Kashmir Institute of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deaths

Keywords

Pralidoxime, atropine, organophosphorous poisoning.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Factorial Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo was given to compare the effects

Arm Title

Pralidoxime

Arm Type

Active Comparator

Arm Description

Pralidoxime for treating organophosphorous poisoning patients

Intervention Type

Drug

Intervention Name(s)

Pralidoxime

Other Intervention Name(s)

Oximes

Intervention Description

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

Primary Outcome Measure Information:

Title

mortality rate

Time Frame

upto one year

Secondary Outcome Measure Information:

Title

duration of ventilation

Time Frame

upto one year

Other Pre-specified Outcome Measures:

Title

duration of ICU stay

Time Frame

upto one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Showkat Gurcoo, MD

Organizational Affiliation

SKIMS

Official's Role

Study Director

Facility Information:

Facility Name

Sheri kashmir insititute of medical sciences

City

Srinagar

State/Province

Srinagar Kashmir

ZIP/Postal Code

190006

Country

India

12. IPD Sharing Statement

Citations:

PubMed Identifier

17706760

Citation

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.

Results Reference

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

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