Determination and comparison of the effects of hypo-caloric and full-caloric enteral feeding on metabolic stress indices of patients with multiple trauma, during the first week of admission in the general intensive care unit
Design
Controlled clinical trial with parallel group, single-blind, randomized,
Settings and conduct
The present study was a single-blind controlled clinical trial examining the effect of calorie intake on metabolic stress indices in patients with general trauma.Participants (80 individuals, 18 to 65 years) will be recruited from the intensive care unit of Shahid Kamyab Hospital and will be divided into two groups of hypo-calorie and full-calorie diet recipients.Patients in both groups will be provided with intestinal nutritional support during the first 24-48 hours after stabilization of the hemodynamic status and will be fed bolus at three-hour intervals.
Participants/Inclusion and exclusion criteria
Inclusion criteria:age between 18-65 Gastrointestinal tract with normal function and indications of Entral Nutrition Diagnosis of moderate to severe trauma based on GCS (4-14);Exclusion criteria: failure to start enteral nutrition during the first 48 hours of admission Patients who are less than 96 hours in intensive care unit
Intervention groups
Intervention group: Start the intestinal feeding of a patient with a hypo- calorie intake (30-40% of the daily calorie requirement) and gradually increase and reach it (70-80% of the required calorie requirement) and continue feeding at the same rate until day 14
Control group: Start the intestinal feeding of a patient with a full- calorie intake (70-80% of the daily calorie requirement) and gradually increase and reach it (90-95% of the required calorie requirement) and continue feeding at the same rate until day 14
The effects of hypo-caloric and full-caloric enteral feeding on metabolic stress indices of patients with multiple trauma, during the first week
Public title
The effects of hypo-caloric and full-caloric enteral feeding on metabolic stress indices of patients with multiple trauma, during the first week of admission in the general intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18-65 years
Gastrointestinal tract with normal function and indications of Enteral Nutrition
Diagnosis of moderate to severe trauma based on GCS (4-14)
Enteral ability to feed in the first 24 to 48 hours of admission
Completion of informed consent form from patients' first-degree reletives
Exclusion criteria:
failure to start enteral nutrition during the first 48 hours of admission
Presence Cancer, diabetes, and cardiovascular disease
pregnancy
Patients who are less than 96 hours in intensive care unit
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the permuted block randomization method with blocks of size 4 is used. According to the sample size of 80, 20 blocks of size four will be produced using the online site (www.sealedenvelope.com)
Blinding (investigator's opinion)
Single blinded
Blinding description
After conscious reporting from the patient or their companions, the patient is randomly assigned to either hypo-caloric and full-caloric enteral feeding.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Mashhad University of Medical Sciences
Street address
Department of Nutrition, Faculty of Medicine Mashhad University of Medical Sciences (MUMS) Paradise Daneshgah Azadi Square Post code 91779-48564 Mashad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2019-02-05, 1397/11/16
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.574
Health conditions studied
1
Description of health condition studied
multiple truama
ICD-10 code
S00-T98
ICD-10 code description
Injury, poisoning and certain other consequences of external causes
Primary outcomes
1
Description
24 hours urea urine
Timepoint
at the baseline, 7 and 14 days after intervention
Method of measurement
Auto-analyzer
2
Description
Triglyceride
Timepoint
at the baseline, 7 and 14 days after intervention
Method of measurement
Auto-analyzer
3
Description
serum lactate
Timepoint
at the baseline, 7 and 14 days after intervention
Method of measurement
Auto-analyzer
4
Description
Blood Glucose
Timepoint
at the baseline, 7 and 14 days after intervention
Method of measurement
Auto-analyzer
5
Description
Body temperature
Timepoint
at the baseline, 7 and 14 days after intervention
Method of measurement
Rectal temperature measurement using mercury thermometer
6
Description
Resting energy expenditures
Timepoint
at the baseline, 7 and 14 days after intervention
Method of measurement
Indirect calorimetric device
Secondary outcomes
1
Description
Mid arm circumference
Timepoint
At the baseline and 14 days after starting intervention
Method of measurement
Measuring meters
2
Description
Gastrointestinal intolerance
Timepoint
Every day for two weeks
Method of measurement
questionnaire
3
Description
Calorie intake
Timepoint
Every day for two weeks
Method of measurement
questionnaire
4
Description
protein intake
Timepoint
Every day for two weeks
Method of measurement
questionnaire
5
Description
Number of hospital admissions days
Timepoint
Followed for 28 days
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Patients in the intervention group will receive Hypocaloric diet. Subjects of hypocaloric diet group will receive 40 -30 percent of calculated calorie by using indirect calorimetry device during the first 24-48 hours of being in patient, and this amount will be reach to70-80 percent of patient’s need in one week. Patients in the intervention group will be fed 70-80% of their required calories by the end of the intervention (day 14 of hospitalization).
Category
Treatment - Other
2
Description
Control group: Patients in the Control group will receive full-calorie diet. Subjects of full-calorie diet group will receive 70-80 percent of calculated calorie by using indirect calorimetry device during the first 24-48 hours of being in patient, and this amount will be reach to90-95 percent of patient’s need in one week. Patients in the Control group will be fed 90-95% of their required calories by the end of the intervention (day 14 of hospitalization).
Department of Nutrition, Faculty of Medicine Mashhad University of Medical Sciences (MUMS) Paradise Daneshgah Azadi Square Post code 91779-48564 Mashad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 8888
Fax
+98 51 3882 8560
Email
med.faculty@mums.ac.ir
Grant name
Grant code / Reference number
970840
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Roya Ranjbar Miri
Position
M.Sc. student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Medicine Mashhad University of Medical Sciences (MUMS) Paradise Daneshgah Azadi Square Post code 91779-48564 Mashad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
ranjbarr1@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mohammad safarian
Position
Associate professor in Clinical Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Medicine Mashhad University of Medical Sciences (MUMS) Paradise Daneshgah Azadi Square Post code 91779-48564 Mashad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2423
Email
SafarianM@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Roya Ranjbar Miri
Position
M.Sc. student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Medicine Mashhad University of Medical Sciences (MUMS) Paradise Daneshgah Azadi Square Post code 91779-48564 Mashad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7043
Email
ranjbarr1@mums.ac.ir
Web page address
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