Evaluation of a single dose of estradiol valerate on the duration of hospitalization and its consequences in patients with severe burns: A clinical trial
Determining the effectiveness of estradiol valerate injection on the duration of hospitalization and its consequences in patients with severe burns in Rasht hospital in 1400.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 50 patients. To generate random numbers, various packages available in R software will be used.
Settings and conduct
Rasht Province Hospital. Patient, researcher and evaluator of blindness
And samples are randomly selected
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patient with severe burns (second or higher degree burns with an area of more than 20%)
Acute burns which have occurred in less than 24 hours.
Fill out the informed consent form
exclusion criteria:
electric burns
Inhalation burns
People undergoing hormone therapy.
People with a history of estrogen-dependent cancer (breast, uterus, ovary).
Pregnants
Intervention groups
Both groups receive standard burn treatment.
The intervention group will receive standard treatment with estradiol valerate.
The control group will receive standard treatment.
Main outcome variables
Discharge time and speed of recovery (seen daily)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210524051384N7
Registration date:2021-11-23, 1400/09/02
Registration timing:prospective
Last update:2021-11-23, 1400/09/02
Update count:0
Registration date
2021-11-23, 1400/09/02
Registrant information
Name
mohammadreza mobayen
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 8540
Email address
maziar.mobayen@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of a single dose of estradiol valerate on the duration of hospitalization and its consequences in patients with severe burns: A clinical trial
Public title
Evaluation of a single dose of estradiol valerate on the duration of hospitalization and its consequences in patients with severe burns: A clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with severe burns (second or higher degree burns with an area of more than 20%)
Fill out the informed consent form
Acute burns have occurred in less than 24 hours.
Exclusion criteria:
Electric burns
Inhalation burns
People with a history of estrogen-dependent cancer (breast, uterus, ovary)
Pregnant and lactating people
taking phenobarbital, carbamazepine, ritonavir, rifampin,
People with a history of thrombophlebitis and thromboembolism.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, in order to assign patients to intervention and control groups, the restricted randomization approach will be used in the form of block randomization. Blocking is commonly used to balance the number of samples assigned to each of the study groups. This method during sampling causes the sample assigned to each of the study groups to be equal. To prevent the last allocation from being detected in the blocks under consideration, we will consider the size of the blocks to be random with a size of 4 or 6.Various packages in R software will be used to generate random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants (patients) would be blinded by sealed envelopes. It should be noted that each created randomized sequences will be recorded on a card, and the cards will be put inside the envelopes respectively. In order to blind researcher, similar syringes, the same color injection solutions for the control and intervention groups will be used. The analyzer will also be blinded according to coding of envelope and syringes .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Guilan University of Medical Sciences
Street address
Namjoo St., Velayat Hospital (3rd floor), Clinical Development Center
City
rasht
Province
Guilan
Postal code
4144666949
Approval date
2021-10-27, 1400/08/05
Ethics committee reference number
IR.GUMS.REC.1400.358
Health conditions studied
1
Description of health condition studied
burn
ICD-10 code
T20
ICD-10 code description
Burn and corrosion of head, face, and neck
Primary outcomes
1
Description
Discharge time and speed of recovery
Timepoint
daily
Method of measurement
Based on patients' records
Secondary outcomes
1
Description
Discharge status
Timepoint
daily
Method of measurement
view of patient file
2
Description
Duration of hospitalization in the ICU
Timepoint
daily
Method of measurement
patient record
3
Description
Comparison of changes in inflammatory factor IL-6
Timepoint
on day 1 (before injection of estradiol valerate) and 3 and 7
Method of measurement
ELISA
4
Description
Itching rate
Timepoint
daily
Method of measurement
based on the patient's statements
5
Description
Comparison of changes in laboratory indices of serum levels of CRP, ferritin, LDH, CPK
Timepoint
On days 1, 3 and 7
Method of measurement
By laboratory kits
6
Description
INR, PT, PTT
Timepoint
On days 1, 3 and 7
Method of measurement
By laboratory kits
7
Description
Serum and blood transfusion
Timepoint
daily
Method of measurement
based on patient records
Intervention groups
1
Description
Intervention group: Intervention group: Intervention group: Patients receiving estradiol valerate upon arrival after receiving consent, standard treatment and single dose of estradiol valerate (manufactured by Abu Reihan factory, Iran) at a dose of 0.5 ml / kg intramuscularly, none Patients included in the study (both intervention group and control group) will not be deprived of routine treatment of burn patients.
Category
Treatment - Drugs
2
Description
Control group: The control group will receive standard treatment. None of the patients included in the study (both intervention group and control group) will be deprived of routine treatment of burn patients.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
velayat hospital
Full name of responsible person
Dr. Mohammad Reza Mobin
Street address
Namjoo Street, Velayat Hospital
City
rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Email
Maziar.mobayen@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Naghipour
Street address
Namjoo St., in front of 17 Shahrivar Hospital, Deputy of Research and Technology
City
rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3333 6394
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Mobayen
Position
Director of the Department of Surgery, Head of the Burn and Plastic Surgery Hospital, Head of the Bu
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Namjoo Street
City
rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Email
Maziar.mobayen@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Mobayen
Position
General Surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Namjoo Street
City
rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Email
Maziar.mobayen@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Saba Abedi mahzoon
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Namjoo Street
City
rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Email
sabaaabediii@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available