Comparison of the effects of regular dose and elevated dose of trace element supplementation on nutritional status and general condition of burned injured patients admitted to BICU
Comparison of the effects of regular dose and elevated dose of trace element supplementation on nutritional status and general condition of burned injured patients admitted to Burn ICU
Design
Randomized clinical trial with control group, Parallel groups, single blinded, sample size is 48
Settings and conduct
This study will be performed in Taleghani hospital in Ahvaz in a single-blinded manner. 48 patients will be divided into two groups of intervention and control by block randomization method.The intervention group will be injected with two doses of Addamel each time; and the control group will be injected with one.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 18 years
Staying in ICU for more than 72 hours
Burn percentage: between 20 and 60
Exclusion criteria:
Patients with liver disorders
Patients with Nephrotic Syndrome
Hemodynamic instability
Increased lactate in serum
Pregnancy
Intervention groups
Control group: on the first ,third and fifth day of hospitalization patients will receive one dose of Addamel in the form of injection supplement.
Intervention group: on the first ,third and fifth day of hospitalization patients will receive two doses of Addamel in the form of injection supplement.
Main outcome variables
hospitalization days
ventilation time
hospital-acquired infection rate
changes in patients' nutritional status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200115046141N1
Registration date:2020-03-10, 1398/12/20
Registration timing:prospective
Last update:2020-03-10, 1398/12/20
Update count:0
Registration date
2020-03-10, 1398/12/20
Registrant information
Name
Pegah Sajadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3337 1272
Email address
sajadi.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2021-01-04, 1399/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of regular dose and elevated dose of trace element supplementation on nutritional status and general condition of burned injured patients admitted to BICU
Public title
trace element supplementation in burned patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Staying in ICU for more than 72 hours
Burn percentage: between 20 and 60
Exclusion criteria:
Patients with liver disorders
Patients with Nephrotic Syndrome
Hemodynamic instability
Increased lactate in serum
Pregnancy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization with computer software
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants (patients) will not be informed that they are in the control or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Jundishapur university of Medical Sciences
Street address
No .19. East 23 street. Kian abad
City
Ahvaz
Province
Khouzestan
Postal code
6155764566
Approval date
2020-02-24, 1398/12/05
Ethics committee reference number
IR.AJUMS.REC.1398.909
Health conditions studied
1
Description of health condition studied
burn
ICD-10 code
T30-2, T30
ICD-10 code description
Burn of second degree, body region unspecified, Burn of third degree, body region unspecified
Primary outcomes
1
Description
hospitalization days
Timepoint
at the end of the study
Method of measurement
based on the number of the days
2
Description
ventilation time
Timepoint
at the end of the study
Method of measurement
based on the number of the days
3
Description
hospital-acquired infection rate
Timepoint
first , third and fifth day of hospitalization
Method of measurement
white blood cell count
4
Description
changes in patients' nutritional status
Timepoint
first , third and fifth day of hospitalization
Method of measurement
measuring blood indexes like albumin , creatinine, sodium and potassium
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: on the first ,third and fifth day of hospitalization patients will receive two doses of Addamel in the form of injection supplement.(three times and each time two doses) each dose contains:1.1 milligrams Iron,6.5 milligrams Zinc , 1.3 milligrams Copper, 0.27 milligrams Manganese, 0.13 milligrams Iodine , 32 micrograms Selenium , 10 micrograms Chromium , 19 micrograms Molybdenum, and 0.95 milligrams Fluorine
Category
Prevention
2
Description
Control group: on the first ,third and fifth day of hospitalization patients will receive one dose of Addamel in the form of injection supplement.(three times and each time one dose) each dose contains:1.1 milligrams Iron,6.5 milligrams Zinc , 1.3 milligrams Copper, 0.27 milligrams Manganese, 0.13 milligrams Iodine , 32 micrograms Selenium , 10 micrograms Chromium , 19 micrograms Molybdenum, and 0.95 milligrams Fluorine
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital for burn patients
Full name of responsible person
Peyman Nejati
Street address
across from number 23 police station, phase 2 of Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
6187954386
Phone
+98 61 3554 0255
Email
p.nejati97@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz Jundishapur University of Medical Science, Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Web page address
Grant name
Grant code / Reference number
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
Pegah Sajadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 19, East 23 Ave, Kian Abad
City
Ahvaz
Province
Khouzestan
Postal code
6155764566
Phone
+98 61 3337 1272
Fax
Email
sajadi.p@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Durdana Husain
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Ahvaz Jundishapur University of Medical Science, Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
husain-d@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Pegah Sajadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 19, East 23 Ave, Kian Abad
City
Ahvaz
Province
Khouzestan
Postal code
6155764566
Phone
+98 61 3337 1272
Fax
Email
sajadi.p@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the financial support of this research project by Ahvaz Jundishapur University of Medical Science ,the study data will not be allowed to be published after the intervention.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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