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Scopolamine Treatment for Patients With Organophosphate Poisoning

Primary Purpose

Neurotoxicity Syndromes

Status

Withdrawn

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Placebo

About this trial

This is an interventional treatment trial for Neurotoxicity Syndromes focused on measuring Insecticides, Organophosphate, Scopolamine, randomized control study, Organophosphate or carbamate intoxication

Eligibility Criteria

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

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)

Sites / Locations

Rambam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

IV Scopolamine 0.25mg in adults and 0.006mg/kg in children Q4h

IV Look alike drug Q 4h

Outcomes

Primary Outcome Measures

Improvement in neurological status as measured by the Glasgow Coma Scale

Duration of seizures.

Number of days on ventilator

Secondary Outcome Measures

Total cumulative dose of atropine

Need for benzodiazepines

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 3 month

Survival at 24 hours

Survival to discharge

Number of days in hospital

Full Information

NCT ID

NCT00389259

First Posted

October 17, 2006

Last Updated

April 4, 2011

Sponsor

Assaf-Harofeh Medical Center

Collaborators

Israeli MOH, International Diabetes Federation

1. Study Identification

Unique Protocol Identification Number

NCT00389259

Brief Title

Scopolamine Treatment for Patients With Organophosphate Poisoning

Official Title

Scopolamine Treatment for Patients With Organophosphate Poisoning - a Randomized, Double Blind, Placebo-Controlled Study.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Withdrawn

Study Start Date

October 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Assaf-Harofeh Medical Center

Collaborators

Israeli MOH, International Diabetes Federation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

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

Neurotoxicity Syndromes

Keywords

Insecticides, Organophosphate, Scopolamine, randomized control study, Organophosphate or carbamate intoxication

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

IV Scopolamine 0.25mg in adults and 0.006mg/kg in children Q4h

Arm Title

Arm Type

Placebo Comparator

Arm Description

IV Look alike drug Q 4h

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

IV placebo q4h

Primary Outcome Measure Information:

Title

Improvement in neurological status as measured by the Glasgow Coma Scale

Time Frame

1 week

Title

Duration of seizures.

Time Frame

1 week

Title

Number of days on ventilator

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Total cumulative dose of atropine

Time Frame

1 week

Title

Need for benzodiazepines

Time Frame

1 week

Title

Number of days in the ICU

Time Frame

2 weeks

Title

Adverse effects and complications

Time Frame

2 weeks

Title

Neurological assessment at discharge

Time Frame

2 weeks

Title

Neurological assessment 3 month after the exposure

Time Frame

3 month

Title

Neuro-cognitive assessment at 3 month

Time Frame

3 month

Title

Survival at 24 hours

Time Frame

24 hours

Title

Survival to discharge

Time Frame

4 weeks

Title

Number of days in hospital

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eran Kozer, MD

Organizational Affiliation

Assaf-Harofeh Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rambam Hospital

City

Haifa

Country

Israel

12. IPD Sharing Statement

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Scopolamine Treatment for Patients With Organophosphate Poisoning

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