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Scopolamine Treatment for Patients With Organophosphate Poisoning

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ClinicalTrials.gov Identifier: NCT00389259
Recruitment Status : Withdrawn
First Posted : October 18, 2006
Last Update Posted : April 5, 2011
Sponsor:
Collaborators:
Israeli MOH
International Diabetes Federation
Information provided by:
Assaf-Harofeh Medical Center

Tracking Information
First Submitted Date  ICMJE October 17, 2006
First Posted Date  ICMJE October 18, 2006
Last Update Posted Date April 5, 2011
Study Start Date  ICMJE October 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2007)
  • Improvement in neurological status as measured by the Glasgow Coma Scale [ Time Frame: 1 week ]
  • Duration of seizures. [ Time Frame: 1 week ]
  • Number of days on ventilator [ Time Frame: 1 week ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2006)
  • Improvement in neurological status as measured by the Glasgow Coma Scale
  • Duration of seizures.
  • Number of days on ventilator
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2007)
  • Total cumulative dose of atropine [ Time Frame: 1 week ]
  • Need for benzodiazepines [ Time Frame: 1 week ]
  • Number of days in the ICU [ Time Frame: 2 weeks ]
  • Adverse effects and complications [ Time Frame: 2 weeks ]
  • Neurological assessment at discharge [ Time Frame: 2 weeks ]
  • Neurological assessment 3 month after the exposure [ Time Frame: 3 month ]
  • Neuro-cognitive assessment at 3 month [ Time Frame: 3 month ]
  • Survival at 24 hours [ Time Frame: 24 hours ]
  • Survival to discharge [ Time Frame: 4 weeks ]
  • Number of days in hospital [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2006)
  • Total cumulative dose of atropine
  • Need for benzodiazapines
  • Number of days in the ICU
  • Adverse effects and complications
  • Neurological assessment at discharge
  • Neurological assessment 3 month after the exposure
  • Neuro-cognitive assessment at one month and 3 month
  • Survival at 24 hours
  • Survival to discharge
  • Number of days in hospital
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Scopolamine Treatment for Patients With Organophosphate Poisoning
Official Title  ICMJE Scopolamine Treatment for Patients With Organophosphate Poisoning - a Randomized, Double Blind, Placebo-Controlled Study.
Brief Summary

Organophosphate (OP) compounds are a major threat as chemical warfare agents or in terrorist act. OPs are also the active ingredient of many insecticides. Ingestion of insecticides is a common cause of death among people who commit suicide in developing countries. OPs poisoning also frequently occurs after accidental exposure to agricultural OPs and in children as a result of unintentional ingestion.

The use of competitive inhibitors of acetylcholine other than atropine for patient with organophosphate (OP) poisoning is controversial. Because scopolamines' ability to cross the blood brain barrier is better than atropine, it has been suggested that scopolamine should be used OP poisoned patients who have central nervous system (CNS) manifestations. However there is controversy regarding its potential benefit in the treatment of organophosphate poisoning in humans. To the best of our knowledge there are no randomised controlled studies on the use of scopolamine in humans. This prospective randomised controlled study is aimed to determine whether adding scopolamine to the standard treatment of atropine and oximes in patients with CNS symptoms of OP poisoning improve the outcome.

Detailed Description Objective: to determine whether adding scopolamine to the standard treatment of atropine and oximes improve the outcome of patients with OP poisoning and CNS manifestations. Design: A multi-center, randomized, double blind, placebo controlled study. Setting: Emergency Departments & Intensive Care Units in Israel. Participants: Patients 2 -60 years old with acute OP poisoning and CNS manifestations. Interventions: In addition to standard treatment with atropine and obidoxime, eligible patients will be randomly assigned to one of two treatment groups, scopolamine group, and placebo group (both given in the same volume). Scopolamine will be given IM or IV in a dose of 0.25mg for adults and 0.006mg/kg for children every 4 hours. At least three doses of scopolamine (or placebo) will be given. The medical staff will be blinded to the treatment given. Main outcome measures: Improvement in neurological status, duration of seizures and number of days on ventilator. Data analysis: The main outcome measures, will be compared using the Student's t-test or the Mann-Whitney tests as appropriate. The *2 or Fisher Exact tests, as appropriate, will be used for comparisons of categorical variables. We will use multiple logistic regression to examine the extent to which variables predict success or failure of the treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neurotoxicity Syndromes
Intervention  ICMJE Drug: Placebo
IV placebo q4h
Study Arms  ICMJE
  • Experimental: A
    IV Scopolamine 0.25mg in adults and 0.006mg/kg in children Q4h
    Intervention: Drug: Placebo
  • Placebo Comparator: B
    IV Look alike drug Q 4h
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Estimated Enrollment  ICMJE
 (submitted: November 1, 2007)
50
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age: 2- 60 years
  • At least two of the following three criteria:

    • Known exposure to an organophosphate or carbamate insecticide in the last 72 hours.
    • Symptoms and signs typical to organophosphate poisoning involving at least two systems (gastrointestinal, respiratory, skin, eyes,) See appendix
    • Low levels of plasma butyrylcholinesterase (less than 50% of the lower normal range )
  • CNS involvement in the first 72 hours after exposure: determined by finding at least one of the following major criteria or at least two of the minor criteria

Major criteria for CNS involvement:

  • Seizures
  • Extrapyramidal or Parkinson like symptoms
  • Decreased level of consciousness (GCS< 12)

Minor criteria for CNS involvement:

  • GCS 14-12
  • Confusion
  • Hallucinations

Exclusion Criteria:

  • Hypersensitivity to scopolamine
  • Glaucoma, narrow-angle (angle-closure)
  • Tachyarrhythmias, congestive heart failure
  • Obstructive gastrointestinal disease
  • Myasthenia Gravis
  • Reflux esophagitis
  • Ulcerative colitis
  • Known obstructive uropathy
  • Pregnancy
  • Patient or legal guardian unable to give informed consent (see comment under ethics)
  • Severe co-morbidity (multi-trauma, advanced cancer, etc)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00389259
Other Study ID Numbers  ICMJE 70/04*1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Assaf-Harofeh Medical Center
Collaborators  ICMJE
  • Israeli MOH
  • International Diabetes Federation
Investigators  ICMJE
Principal Investigator: Eran Kozer, MD Assaf-Harofeh Medical Center
PRS Account Assaf-Harofeh Medical Center
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP