The effect of single dose vitamin D injection on renal function in trumatic patients hospitalized in ICU
Design
A randomized clinical trial with a control group with parallel, double-blind, randomized groups, on 60 patients
Blocks of 4 random numbers are used for randomization
Settings and conduct
Trauma patients in the intensive care unit of Ahvaz Golestan Hospital, if they meet the inclusion criteria and do not have the exclusion criteria, after obtaining written consent, they will be randomly divided into two groups A and B based on blocks of 4 random numbers. no one knows about it except the hospital pharmacist
Demographic information and trauma severity index, recorded at the beginning of hospitalization.
Blood urea and creatinine levels are recorded daily, and anthropometric indices (BMI, abdominal circumference) are recorded on arrival and at the end of the 28th day or day of discharge.
Both groups receive an intramuscular dose of 300,000 units of vitamin D or placebo during the first 24 hours of hospitalization.
duration of intensive care unit hospitalization, 28-day ventilator free days, and the discharge or death are recorded.
Blinding: patients or families, nurses, researchers and statistical analysts will not know about the drug group, and drug injection will be done by hospital pharmacist.
Participants/Inclusion and exclusion criteria
Inclusion : trauma patient with a revised trauma score greater than or equal to 6 and over 18 years of age who has been hospitalized in the intensive care unit for at least 24 hours
Exclusion : having chronic kidney disease, autoimmune disease or cancer
Intervention groups
The control group : received a single dose of intramuscular placebo on arrival to intensive care unit
The vitamin D group : received a single dose of intramuscular vitamin D on arrival to intensive care unit
Main outcome variables
Cr
Bun
24 hr urine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221121056570N2
Registration date:2023-08-15, 1402/05/24
Registration timing:prospective
Last update:2023-08-15, 1402/05/24
Update count:0
Registration date
2023-08-15, 1402/05/24
Registrant information
Name
Mohsen Savaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 4536
Email address
savaie-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of single dose Vitamin D injection on renal function in Patients with Traumatic Injuries Hospitalized in Intensive Care Unit
Public title
Vitamin D in Trauma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Traumatic patient
Age more than 18
Hospitalized in intensive care unit more than 24 hours
Revised trauma score (RTS) >=6
New trauma score (NTS) >=8
Exclusion criteria:
Chronic renal failure
Cancer
Autoimione disease
Abstinece of patient
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by the method of individual assigning of random numbers with blocks of 4. The tool used to generate random numbers with blocks of 4 is the online software of the Sealedenvelope.com website. Every new patient who is admitted to the intensive care unit, if he meets the inclusion criteria for entering the study, will be placed in one of the A or B groups in the order of arrival and based on the order of randomly generated numbers.
For allocation concealment, except for the hospital pharmacist who prepares the drugs for injection and is not present in the study, no one else knows which of the placebo or vitamin D groups referred to each of the A and B groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients (or the patient's family), nurses (care providers), research assistants (who are in charge of data collection) and the statistical analyst will not know about the drug groups (intervention or control) and delivery of medication will be done by a person selected from outside the department (hospital pharmacist).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJUMS
Street address
Golestan
City
Ahwaz
Province
Khouzestan
Postal code
6136854578
Approval date
2023-01-17, 1401/10/27
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1401.171
Health conditions studied
1
Description of health condition studied
Acute kidney failure
ICD-10 code
N17
ICD-10 code description
Acute kidney failure
Primary outcomes
1
Description
Creatinin
Timepoint
Before intervention and daily till discharge from ICU (maximum 28 days)
Method of measurement
biochemical auto-analyser
Secondary outcomes
1
Description
Blood urea nitrogen
Timepoint
Before intervention and daily till 28 days or discharge time
Method of measurement
Biochemical auto-analyser
2
Description
Body mass index
Timepoint
Before intervention and 28th day or at discharge time
Method of measurement
Based on the result of dividing weight in kilograms by height in meters
3
Description
Abdominal circumference
Timepoint
Before intervention and 28th day or at discharge time
Method of measurement
Mesurment with a meter
4
Description
Mortality
Timepoint
After 28 days or at discharge time
Method of measurement
Alive or dead
5
Description
Ventilator free days (in first 28 days)
Timepoint
After 28 days or at discharge time
Method of measurement
The number of days of the first 28 days that the patient was not connected to the ventilator
Intervention groups
1
Description
This group will receive an intramuscular dose of placebo (1 mililiter of isotonic NACL 0.9% manufactured by Shahid Ghazi Pharmaceutical company, Tabriz, Iran) during the first 24 hours of hospitalization.
Category
Placebo
2
Description
Intervention group: This group will receive an intramuscular dose of medicine (300,000 units of vitamin D manufactured by Iran's Darupakhsh Pharmaceutical Company) during the first 24 hours of hospitalization.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Dr mohsen savaie
Street address
Golestan hospital
City
Ahwaz
Province
Khouzestan
Postal code
6136854578
Phone
+98 916 676 3664
Email
drsavaie@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
mehrnoosh zakerkish
Street address
Golestan hospital
City
Ahwaz
Province
Khouzestan
Postal code
6136854578
Phone
+98 916 113 0854
Email
zakerkishm@yahoo.com
Grant name
Faculty members grant
Grant code / Reference number
PAIN-0126
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mosen savaie
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Golestan
City
Ahwaz
Province
Khouzestan
Postal code
6136854578
Phone
+98 61 3320 4558
Email
drsavaie@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohsen savaie
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Golestan hospital
City
Ahwaz
Province
Khouzestan
Postal code
6136854578
Phone
+98 61 3320 4558
Email
drsavaie@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Monavareh nejadrasoli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Golestan hospital
City
Ahwaz
Province
Khouzestan
Postal code
6136854578
Phone
+98 61 3320 4558
Email
Mnvrhnjd@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
All data will be available from the publication of the research paper
To whom data/document is available
The data will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers can request to receive data for research and clinical uses and to conduct systematic reviews and meta-analyses
From where data/document is obtainable
It is possible to receive data by sending an email (drsavaie@gmail.com)
What processes are involved for a request to access data/document
The data will be sent by email no later than one month after the request by academic researchers and scientific centers
Comments
If requested by the journal publishing the article, the data can be uploaded on the journal's website