Effect of add-on therapy with Ranolazine on reducing tissue ischemia and improvement of clinical outcome in patients with severe burn: A clinical trial
Effect of add-on therapy with Ranolazine on reducing tissue ischemia and improvement of clinical outcome in patients with severe burn
Design
This study is a parallel single blind clinical trial on 78 patients with intervention and control group (39 patients in each group). Patients in the intervention group will be treated with ranolazine 500 mg for 5 days. Restricted randomization method in the form of block randomization will be used to allocate patients into intervention and control groups.
Settings and conduct
Location: Velayat Hospital (Rasht, Iran). The researcher, and evaluator are blinded and samples are randomly selected.
Participants/Inclusion and exclusion criteria
* Inclusion criteria: Age range from 18 to 65 years/ Acute burn in less than 6 hours/ TBSA between 20 - 50%/ patients of ASA class I (a normal healthy person)/ Fill out the informed consent.
* Non-inclusion: Having severe hypertension BP ≥ 160/90 mmHg or systolic pressure below 100 mm Hg; ischemic changes in ECG; Heart rate less than 70 beats per minute; Pregnant women; Peripheral vascular disease; Presence of inhalation injury; Presence of burn shock (including decreased cardiac output, increased vascular resistance, hypovolemia and hypoperfusion following severe burns); Electrical and chemical burns; Kidney or liver failure caused by burns (according to the kidney and liver metabolism of the drug); Presence of drug interactions with the patient's previous medications.
Intervention groups
intervention group ( patients receiving ranolazine along with standard burn treatment) and control group (patients receiving standard burn treatment)
Main outcome variables
1) Graft to TBSA ratio; 2) Mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210524051384N10
Registration date:2023-06-20, 1402/03/30
Registration timing:prospective
Last update:2023-06-20, 1402/03/30
Update count:0
Registration date
2023-06-20, 1402/03/30
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
2023-06-22, 1402/04/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of add-on therapy with Ranolazine on reducing tissue ischemia and improvement of clinical outcome in patients with severe burn: A clinical trial
Public title
Effect of add-on therapy with Ranolazine on reducing tissue ischemia and improvement of clinical outcome in patients with severe burn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 18 to 65 years
Acute burn in less than 6 hours
Total body surface area (TBSA) between 20 - 50%
patients of American Society of Anesthesiologists (ASA) class I (a normal healthy person)
Fill out the informed consent
Exclusion criteria:
Having severe hypertension blood pressure (BP) ≥ 160/90 mmHg or systolic pressure below 100 mmHg
Ischemic changes in electrocardiogram (ECG)
Heart rate less than 70 beats per minute
Pregnant women
Peripheral vascular disease
Presence of inhalation injury
Presence of burn shock (including decreased cardiac output, increased vascular resistance, hypovolemia and hypoperfusion following severe burns)
Electrical and chemical burns
Kidney or liver failure caused by burns (according to the kidney and liver metabolism of the drug)
Presence of drug interactions with the patient's previous medications
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, in order to assign patients to the intervention and control groups, the limited randomization approach will be used in the block randomization method. In order to prevent revealing the last allocation in the blocks, we will consider the size of the blocks randomly with sizes 4 and 6. The sequences inside each block are randomly determined so that half of the members of each block are assigned to the control group and the other half to the intervention group. For this purpose, the "Sealed envelope” online software is used to determine the blocks, so that the random blocks and sequences of each one are specified, and then the patients are assigned to the intervention and control groups based on the specified sequence.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding in this study will be done in such a way that the patients were assigned to the intervention and control groups by the statistician, and the student colleagues will be responsible for conducting the interventions. Evaluation and completion of the checklists on specific determined times was the responsibility of the surgeon and project manager, who was not aware of the grouping of the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Guilan University of Medical Sciences
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2023-05-17, 1402/02/27
Ethics committee reference number
IR.GUMS.REC.1402.101
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
Graft to TBSA (total body surface area) percent ratio
Timepoint
At discharge
Method of measurement
Measurements based on Wallace criteria
2
Description
Mortality
Timepoint
At discharge
Method of measurement
Based on the clinical outcome recorded in the patients' files
Secondary outcomes
1
Description
Length of hospital stay
Timepoint
At discharge
Method of measurement
Based on patient's file
2
Description
SIRS (Systemic inflammatory response syndrome)
Timepoint
On the 1st, 3rd and 7th days of hospitalization
Method of measurement
Based on criteria including temperature, heart rate, respiratory rate, and WBC (white blood cell) count
3
Description
Infection
Timepoint
On the 1st, 3rd and 7th days of hospitalization
Method of measurement
Based on clinical decision of doctor
Intervention groups
1
Description
Intervention group: The treatment with oral ranolazine 500 mg tablets for patients in the intervention group will be started in the emergency room in such a way that the maximum time interval between the occurrence of the accident and the start of treatment is 6 hours. It should be noted that patients in the intervention group will take the prescribed pill with water. The medicine will continue to be taken every 12 hours until the fifth day after the injury. It should be mentioned that the patients received standard burn treatment during the entire hospitalization. These measures include: Resuscitation with fluids based on the Parkland formula and modification based on urinary output, monitoring vital signs and laboratory findings, regular washing and wound debridement and dressing using local antibiotics and surgical debridement and grafting based on the patient's need. Additionally, if any complication caused by the drug was observed in the study group, the patient was immediately excluded from the study and all necessary measures were taken to eliminate the complication and recover the patient as quickly as possible.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group receive standard burn treatments since the admission to emergency room. These measures include: Resuscitation with fluids based on the Parkland formula and modification based on urinary output, monitoring vital signs and laboratory findings, regular washing and wound debridement and dressing using local antibiotics and surgical debridement and grafting based on the patient's need. During the hospitalization, the required information will be collected from the patients. This information includes demographic data, vital signs, renal factors, local symptoms such as infection and itching, graft size, clinical outcome and length of hospitalization.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Dr. Mohammadreza Mobayen
Street address
Namjoo st.
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.Mohammadreza Naghipour
Street address
Deputy of Research and Technology, in front of 17 Shahrivar Hospital, Namjoo St
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
Dr. Mohammad Reza Mobayen
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Namjou st.
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
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Namjou st.
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
Seyyed Mohammad Hossein Mazloum
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Namjou st.
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Email
Smhmazloum@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