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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025240
Receipt No. R000029034
Scientific Title Benefits of Magnesium Sulfate in Organophosphate Toxicity
Date of disclosure of the study information 2017/12/31
Last modified on 2018/05/07

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Basic information
Public title Benefits of Magnesium Sulfate in Organophosphate Toxicity
Acronym Benefits of Magnesium Sulfate in Organophosphate Toxicity
Scientific Title Benefits of Magnesium Sulfate in Organophosphate Toxicity
Scientific Title:Acronym Benefits of Magnesium Sulfate in Organophosphate Toxicity
Region
Asia(except Japan)

Condition
Condition Organophosphate toxicity
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of magnesium sulfate as adjunctive treatment to atropine therapy ("atropinization") in treatment of organophosphate toxicity.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rates of morbidity and mortality in the hospital, and up to ten days post-discharge.
Key secondary outcomes Side effects/toxicities attributable to magnesium sulfate treatment;
Length of hospital stay;
Duration of signs and symptoms of toxicity;
Doses of other drugs used.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment with 4g of magnesium sulfate IV + up to 10 g IM in addition to standard therapy with atropine.
Interventions/Control_2 Standard therapy with atropine.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
12 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria All patients presenting to the Poison Control Centre diagnosed with moderate to severe organophosphate toxicity.
Key exclusion criteria Heart block on ECG;
History of Myocardial Infarction;
History of hypersensitivity to magnesium sulfate;
Hypercalcemia and/or hypermagnesemia.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Omar Abbas Ahmed Malik
Organization Dow University of Health Sciences
Division name Dow Medical College
Zip code
Address 31/1, Zulfiqar Street 1, Phase 8, DHA, Karachi, Pakistan
TEL 00923362363569
Email omar.a.a.malik@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Omar Abbas Ahmed Malik
Organization Dow University of Health Sciences
Division name Dow Medical College
Zip code
Address 31/1, Zulfiqar Street 1, Phase 8, DHA, Karachi, Pakistan
TEL 00923362363569
Homepage URL
Email omar.a.a.malik@gmail.com

Sponsor
Institute Jinnah Postgraduate Medical Centre
Institute
Department

Funding Source
Organization Self-funded.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 13 Day
Last modified on
2018 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029034

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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