Evaluate the prophylactic role of fresh frozen plasma in reducing renal complications in children presenting with severe hemoglobinuria followed by scorpion stinging
Acute kidney injury is frequently seen in stung patients with Hemiscorpius lepturus scorpion. Acute kidney injury refers to 2-fold increase in serum creatinine levels or reduced kidney filtration rate by half. In addition to decline in renal filtration, other findings suggest kidney damage are proteinuria, pyuria and hematuria. The use of fresh frozen plasma (FFP), in scorpion stung patients with hemolytic uremic syndrome (HUS) was followed by a good therapeutic results.
Objectives: We decided to study the effect of FFP on the prevention of acute kidney injury and HUS in scorpion stung patients referred to Abuzar hospital, Ahvaz, Iran (as a single center study). This study is double blind and blinding is done for research analyzers. In this interventional (phase 3) study, we will include scorpion stung patients with gross hemoglobinuria and will classify them to two 48 groups as intervention and control groups. Patients with a history of renal failure or hematuria will excluded. Patents in intervention group received 10 cc/kg FFP every 12 hours for 3 days. We won’t use placebo in control group. We will evaluate serum creatinine and urine protein as primary outcome and duration of hospitalization as secondary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903103122N2
Registration date:2015-09-05, 1394/06/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-05, 1394/06/14
Registrant information
Name
Ehsan Valavi
Name of organization / entity
Ahvaz Jundishapur University
Country
Iran (Islamic Republic of)
Phone
+98 61 1444 3052
Email address
valavi.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the prophylactic role of fresh frozen plasma in reducing renal complications in children presenting with severe hemoglobinuria followed by scorpion stinging
Public title
Fresh frozen plasma prophylaxis role in reducing renal complications of scorpions sting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Gross hemoglobinuria after scorpion stinging; informed consent.
Exclusion criteria: patients with a history of renal failure; Patients with the past history of hematuria or on the first urine test.
Age
To 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur university of medical sciences
Street address
Golestan Ave.
City
Ahvaz
Postal code
Approval date
2014-10-18, 1393/07/26
Ethics committee reference number
ajums.REC.1393.280
Health conditions studied
1
Description of health condition studied
Renal failure
ICD-10 code
N-17, N18,
ICD-10 code description
Renal failure
Primary outcomes
1
Description
Creatinine
Timepoint
Daily
Method of measurement
Mg/dl
2
Description
Urine Protein
Timepoint
Daily
Method of measurement
Dipstic
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
Daily
Method of measurement
Day
Intervention groups
1
Description
Intervention group: Fresh frozen plasma 10cc/kg every 12 hour for 3 days
Category
Treatment - Drugs
2
Description
Control group: We won’t use placebo in control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Abuzar Children Hospital
Full name of responsible person
Ehsan valavi
Street address
Abuzar Children Hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology
Full name of responsible person
Dr. Saki
Street address
Golestan Ave.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Abouzar Hospital
Full name of responsible person
Ehsan Valavi
Position
Pediatric Nephrologyst
Other areas of specialty/work
Street address
Abouzar Hospital
City
Ahvaz
Postal code
Phone
+98 61 3444 3052
Fax
Email
dr_ehsan_valavi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Abouzar Hospital
Full name of responsible person
Ehsan Valavi
Position
Pediatric Nephrologyst
Other areas of specialty/work
Street address
Abouzar Hospital
City
Ahvaz
Postal code
Phone
+98 61 3444 3052
Fax
Email
dr_ehsan_valavi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Abuzar Hospital
Full name of responsible person
Ehsan valavi
Position
Pediatric Nephrologyst
Other areas of specialty/work
Street address
Abuzar Hospital
City
Ahvaz
Postal code
6163933874
Phone
+98 61 3444 3052
Fax
+98 613444711
Email
dr_ehsan_valavi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)