Evaluation of the effect of high protein nutritional support in comparison to nutritional support with regular protein intake in intensive care unit patients: a double-blind randomized clinical trial
Evaluation of the effect of high protein nutritional supplements in comparison with regular protein support in patients admitted to ICU of Imam Reza hospital
Design
The present study was an interventional double-blind clinical trial study of the EFFORT Trial.
The subjects were divided into two groups based on random allocation (using permuted block randomization with quadruple blocks) divided into intervention and control groups. The sample size is estimated to be 60 people based on the large EFFORT TRIAL study.
Settings and conduct
Patients will be admitted to the ICU of Imam Reza Hospital after a visit by a specialist physician to evaluate inclusion and exclusion criteria.
Each patient's weight will be measured by a digital bed scale, height through the length of the ulna bone, mid-arm circumference by a non-elastic tape meter.
Laboratory data, demographic data, and drug codex information and relevant questionnaires will then be recorded for each patient. Those selected as the intervention group will be given 2.2 g / kg of Karen's ISO protein daily and in the control group, 1.1 g / kg of Karen's ISO protein daily for 12 days in seven gavages. Patients will be gavaged 7 times every three hours. The gavage solution in the intervention group will be exactly the same as the gavage solution in the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
≥18 years oldꓼ
Nutritionally ‘high-risk”:
Moderate to severe malnutritionꓼ Frailtyꓼ Sarcopeniaꓼ
Ventilation of patientsꓼ
Enteral ability to feedꓼ
Exclusion criteria:
>96 continuous hours of mechanical ventilation before the screeningꓼ
History of diseases such as hepatocirrhosis and non-dialysis end-stage renal disease.
Intervention groups
Intervention group: 2.2 g / kg of Karen's Iso Whey protein per day
Control group: 1.1 g / kg of Karen's Iso Whey protein per day
Main outcome variables
60 days mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180619040151N4
Registration date:2019-11-07, 1398/08/16
Registration timing:registered_while_recruiting
Last update:2019-11-07, 1398/08/16
Update count:1
Registration date
2019-11-07, 1398/08/16
Registrant information
Name
Abdolreza Norouzy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2382
Email address
norouzya@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-11, 1398/07/19
Expected recruitment end date
2020-07-09, 1399/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of high protein nutritional support in comparison to nutritional support with regular protein intake in intensive care unit patients: a double-blind randomized clinical trial
Public title
Determination of the effect of high protein nutritional support in comparison to nutritional support with common protein in intensive care unit patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
≥18 years old
Nutritionally ‘high-risk”: Moderate to severe malnutrition (as defined by local assessments), BMI≤25, Frailty (Clinical Frailty Scale 5 or more). Sarcopenia- (SARC-F score of 4 or more).
Patients who have been ventilated for at least the first 48 hours of admission or expect ventilation to last more than 4 days.
Completion of informed consent form in the first stage of legal guardianship in case of failure in this field to the judge.
Ability to enteral feed in the first 24 to 48 hours of admission.
Lack of participation in any other interventional research project.
Exclusion criteria:
>96 continuous hours of mechanical ventilation before the screening
Expected death or withdrawal of life-sustaining treatments within 7 days from admission
Pregnant
The responsible clinician recognizes that the patient either needs low or high protein regimen
Patients require only parenteral nutrition
History of diseases such as hepatocirrhosis and End-stage renal disease.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting 60 patients based on inclusion criteria, they will be divided into two groups of intervention or control through stratified block randomization by using the numbered, sealed and stapled envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study with the exception of a care provider, the treatment assignment will be concealed from the patients, investigator, outcome assessor, data analyzer, and data and safety monitoring board throughout the study.
Placebo
Not 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
Mashhad University of Medical Sciences, Mashhad, Park Square.
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2018-12-11, 1397/09/20
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.543
Health conditions studied
1
Description of health condition studied
Critical ill patients
ICD-10 code
Z00.01
ICD-10 code description
Encounter for general adult medical examination with abnormal findings
Primary outcomes
1
Description
mortality
Timepoint
mortality in the intensive care unit and days 12 and 60 after intaking protein
Method of measurement
If the patient is discharged from the intensive care unit, the patient will be contacted by telephone.
Secondary outcomes
1
Description
Nutrition Risk in the Critically Ill (NUTRIC) Score
Timepoint
Before intervention, day 7 and 12
Method of measurement
Nutrition Risk in the Critically Ill (NUTRIC) Score
2
Description
Acute Physiology and Chronic Health Evaluation (APACHE II) score changes
Timepoint
Before intervention, day 7 and 12
Method of measurement
Acute Physiology and Chronic Health Evaluation (APACHE II) score
3
Description
Sequential Organ Failure Assessment (SOFA) score
Timepoint
Before intervention, day 3, 5, 7, 9 and 11
Method of measurement
Sequential Organ Failure Assessment (SOFA) Score
4
Description
SARC-F Screen for Sarcopenia changes
Timepoint
Before intervention, day 12
Method of measurement
SARC-F Score
5
Description
Clinical Frailty Scale changes
Timepoint
Before intervention, day 12
Method of measurement
Clinical Frailty Scale score
Intervention groups
1
Description
Intervention group: 2.2 g / kg of Karen's Iso Whey protein per day by gavage feeding method in 12 days. This amount of surplus protein will be given with gavage is given to patients.
Category
N/A
2
Description
Control group: 1.1 g / kg of Karen's Iso Whey protein per day by gavage feeding method in 12 days. (This amount of surplus protein will be given with gavage is given to patients.)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamreza hospital
Full name of responsible person
Alireza sedaghat
Street address
Ebne Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3800 2429
Email
SedaghatAR@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, 18 Daneshgah Ave. Daneshgah Ave
City
Mashhad
Province
South Khorasan
Postal code
9196773117
Phone
+98 51 1882 3255
Fax
+98 51 1882 3251
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
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
Abdolreza Norouzy
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Azadi-squre
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3800 2382
Fax
+98 51 3800 2421
Email
norouzya@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abdolreza Norouzy
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Azadi-squre
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3800 2382
Fax
+98 51 3800 2421
Email
norouzya@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohaddeseh Badpeyma
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Bahonar Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48988
Phone
+98 51 3882 8299
Email
Badpimamh961@mums.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
There is no further information
Study Protocol
No - There is not 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