Evaluation of the effect of oral trehalose on inflammatory factors, oxidative stress and nutritional and clinical status in patients with traumatic head injury receiving enteral nutrition- a pilot study
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General information
2021-11-22, 1400/09/01
2021-12-25, 1400/10/04
2021-1112-2225 00:00:00
Protocol summary
Study aim
To determine the effect of oral trehalose on inflammatory markers, oxidative stress, nutritional and clinical status in patients with traumatic head injury receiving antral nutrition admitted to the intensive care unit
Design
Clinical trial, with parallel groups, double-blind, randomized, phase 3-2 on 20 patients, block randomization method is used
Settings and conduct
Intensive care unit of hospitals in Mashhad.Similarity of medicine and placebo in terms of color, size and smell, lack of knowledge of participants about the type of reception.Twice (beginning and end of the study) 10 cc of venous blood sample is taken from the patient. During the day, they will receive standard hospital gavage containing all of the maltodextrin carbohydrates.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with head trauma in the intensive care unit with stable hemodynamic and metabolic conditions who have GCS≥7 and antral nutrition and tend to participate in the study and do not tolerate foods containing trehalose such as mushrooms.
No entry criteria:Patients with head trauma who have been on Nil Per Os (NPO) for more than 48 hours (not allowed to receive food), have parenteral nutrition (TPN), transferred to other ICUs after one week of hospitalization Have an underlying background (cancer, autoimmune diseases, congenital metabolic diseases), are pregnant or breastfeeding
Intervention groups
Intervention:For a maximum of 12 days, they will receive six servings of standard hospital gavage with a total of 30 grams of carbohydrates provided by trehalose. (Six servings per serving containing 5 grams of trehalose).
Control: For a maximum of 12 days, they will receive standard hospital gavage for all their meals, all of which is carbohydrate-supplied with maltodextrin.
Evaluation of the effect of oral trehalose on inflammatory factors, oxidative stress and nutritional and clinical status in patients with traumatic head injury receiving enteral nutrition- a pilot study
Public title
Evaluation of the effect of oral trehalose in patients with traumatic head injury in ICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-69 years who have suffered head trauma and are hospitalized in the intensive care unit
Stability of hemodynamic and metabolic conditions of the patient in the first 24-48 hours of admission
GCS≥7
Having antral feeding (tube / Tube feeding)
Lack of intolerance to food sources containing trehalose such as mushrooms
Willingness to cooperate and sign the informed consent form after full knowledge of the objectives and method of the study by the individual or legal guardian
Exclusion criteria:
Patients with head trauma who have been on Nil Per Os (NPO) for more than 48 hours (not allowed to receive food)
Head trauma patients receiving parenteral nutrition (TPN)
Patients who have been transferred from other ICUs to the ICU after 1 week of hospitalization
Having underlying cancer, autoimmune diseases, congenital metabolic diseases
Pregnancy and lactation
Age
From 18 years old to 69 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by block method, the measurement of blocks equal to 4 with a ratio of 1: 1 is divided into two groups. Using the site www.sealedenvelope.com, a random sequence of 5 quadruple blocks with two members of control and treatment with equal proportions is created, the specific code of the volunteers and its group therapy are in different packages from 1 to 20. Upon entering each eligible volunteer, the envelopes will be opened once and the treatment group will be special.
Blinding (investigator's opinion)
Double blinded
Blinding description
For proper blindness, the drug and placebo will be exactly the same in color, size, and odor.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Deputy of Research and Technology, Ghorashi Building, next to Hoveyzeh Cinema, Dneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-05-31, 1400/03/10
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.113
Health conditions studied
1
Description of health condition studied
Trauma / head injury. Intracranial injury that involves brain damage
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
C-reactive protein (CRP) changes
Timepoint
Twice: 1- The beginning of the study 2- The 12th day of the study and if the person is discharged earlier than 12 days and is present in the study for at least 3 days; Day of hospital discharge
Method of measurement
Special measuring kit
2
Description
Interleukin 6 (IL-6) changes
Timepoint
Twice: 1- The beginning of the study 2- The 12th day of the study and if the person is discharged earlier than 12 days and is present in the study for at least 3 days; Day of hospital discharge
Method of measurement
Special measuring kit
3
Description
Malondialdehyde (MDA) changes
Timepoint
Twice: 1- The beginning of the study 2- The 12th day of the study and if the person is discharged earlier than 12 days and is present in the study for at least 3 days; Day of hospital discharge
Method of measurement
Special measuring kit
4
Description
superoxide dismutase (SOD) changes
Timepoint
Twice: 1- The beginning of the study 2- The 12th day of the study and if the person is discharged earlier than 12 days and is present in the study for at least 3 days; Day of hospital discharge
Method of measurement
Special measuring kit
5
Description
Total antioxidant capacity (TAC) changes
Timepoint
Twice: 1- The beginning of the study 2- The 12th day of the study and if the person is discharged earlier than 12 days and is present in the study for at least 3 days; Day of hospital discharge
Method of measurement
Special measuring kit
6
Description
Pro oxidant antioxidant balance (PAB)
Timepoint
Twice: 1- The beginning of the study 2- The 12th day of the study and if the person is discharged earlier than 12 days and is present in the study for at least 3 days; Day of hospital discharge
Method of measurement
laboratory test
7
Description
Glutathione (GSH) changes
Timepoint
Twice: 1- The beginning of the study 2- The 12th day of the study and if the person is discharged earlier than 12 days and is present in the study for at least 3 days; Day of hospital discharge
Method of measurement
Special measuring kit
Secondary outcomes
1
Description
Blood sugar
Timepoint
Daily
Method of measurement
Glucometer device
2
Description
blood pressure
Timepoint
Daily
Method of measurement
Blood pressure monitor
3
Description
Lipid profile
Timepoint
Weekly
Method of measurement
blood sample
4
Description
SOFA criteria
Timepoint
Daily
Method of measurement
SOFA Questionnaire
5
Description
APACHE criteria
Timepoint
Twice: 1- The beginning of the study 2- The 12th day of the study and if the person is discharged earlier than 12 days and is present in the study for at least 3 days; Day of hospital discharge
Method of measurement
APACHE Questionnaire
6
Description
lasgow Coma Scale (GCS)
Timepoint
Daily
Method of measurement
Questionnaire
7
Description
glasgow outcome scale
Timepoint
Twice: 1- The beginning of the study 2- The 12th day of the study and if the person is discharged earlier than 12 days and is present in the study for at least 3 days; Day of hospital discharge
Method of measurement
Questionnaire
8
Description
28-day mortality
Timepoint
28 days after admission to the ICU
Method of measurement
If hospitalized: at the patient's bedside, hospital HIS system information, patient electronic hospital records, telephone call
9
Description
60-day mortality
Timepoint
60 days after admission to the ICU
Method of measurement
If hospitalized: at the patient's bedside, hospital HIS system information, patient electronic hospital records, telephone call
Intervention groups
1
Description
Intervention group: For a maximum of 12 days, they will receive six servings of standard hospital gavage containing a total of 30 grams of carbohydrates from trehalose. (Six servings per serving containing 5 grams of trehalose)
Category
Treatment - Other
2
Description
Control group: For a maximum of 12 days, they will receive standard hospital gavage full of maltodextrin at all meals daily.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Kamyab hospital
Full name of responsible person
Dr. Hamid Rezaei
Street address
Fadaiyan-e-Islam Street
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١۶۶۶٣٧۴٧٧
Phone
+98 51 3859 2121
Fax
+98 51 3854 9234
Email
skh.pr@mums.ac.ir
Web page address
https://h-kamyab.mums.ac.ir/
2
Recruitment center
Name of recruitment center
Shahid Hasheminejad Hospital
Full name of responsible person
Dr. Hamid Rezaei
Street address
Mofateh St.
City
Mashhad
Province
Razavi Khorasan
Postal code
51 32737011
Phone
+98 51 3273 7011
Email
hasheminejad@mums.ac.ir
Web page address
https://hasheminejad.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Taqfadi
Street address
Research and Technology Department, Ghorashi Building, next to Hoveyzeh Cinema, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
vcresraech@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?