UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022032 |
|---|---|
| Receipt number | R000025395 |
| Scientific Title | A randomized comparative study between intravenous and intramuscular scorpion antivenom regimens in a tertiary center in Upper Egypt |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2018/08/17 16:44:14 |
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Basic information
Public title
A randomized comparative study between intravenous and intramuscular scorpion antivenom regimens in a tertiary center in Upper Egypt
Acronym
Intravenous and intramuscular scorpion antivenom
Scientific Title
A randomized comparative study between intravenous and intramuscular scorpion antivenom regimens in a tertiary center in Upper Egypt
Scientific Title:Acronym
Intravenous and intramuscular scorpion antivenom
Region
| Africa |
Condition
Condition
Scorpion envenomation
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to compare the efficacy of scorpion antivenom following intramuscular, intravenous routes of administration regarding the fate and occurrence of fatal complications.
Basic objectives2
Others
Basic objectives -Others
the efficacy of scorpion antivenom following intramuscular, intravenous routes of administration
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the efficacy of scorpion antivenom following intramuscular, intravenous routes of administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
the efficacy of scorpion antivenom following intramuscular route of administration
Interventions/Control_2
the efficacy of scorpion antivenom following intravenous route of administration
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
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients presented with a definite history of scorpion sting. Presented to Assiut university hospital for children within 6 hours of the sting. Observation for at least 24 hours.
Key exclusion criteria
Patients with no definite history of scorpion sting.Presentation after 6 hours of the sting.Observation of less than 24 hours.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Khaled Saad |
Organization
Assiut university
Division name
pediatric department
Zip code
Address
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
TEL
+20882413683
khaled.ali@med.au.edu.eg
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Khaled Saad |
Organization
Assiut University, Assiut, Egypt
Division name
Pediatric Department
Zip code
Address
Assiut University, Assiut, Egypt
TEL
+20882368373
Homepage URL
med@aun.edu.eg
Sponsor or person
Institute
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Institute
Department
Personal name
Funding Source
Organization
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
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
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
| 2016 | Year | 05 | Month | 01 | 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
Studies (CBC, cardiac enzymes, renal function and serum electrolytes), need for mechanical ventilation and outcome. Myocarditis, cardiogenic shock, ICU admission, need for mechanical ventilation, mean hospital stay and mortality were significantly lower in those received intravenous antivenom compared with those received intramuscular or both routes of administration
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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 23 | Day |
Last modified on
| 2018 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025395
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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