Protocol summary
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Study aim
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Evaluation of the effect of high-protein nutritional support compared to conventional-protein nutritional support in critically ill patients admitted to the intensive care unit
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Design
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This parallel, randomized, double-blind clinical trial was conducted on 60 ICU patients at Imam Reza Hospital, Mashhad, Iran. Participants were randomly allocated (1:1) using stratified block randomization (by age and sex; block size of 4). An independent statistician generated the allocation sequence using a random number table, and assignments were concealed in opaque, sequentially numbered envelopes, opened only after confirming eligibility.
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Settings and conduct
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Eligible ICU patients at Imam Reza Hospital will be enrolled after specialist assessment. Weight, height (via ulna length), and MUAC will be measured. Demographic, clinical, and laboratory data will be recorded. High- and conventional-protein BTF formulas (2.2 vs. 1.0 g/kg/day) will be prepared in identical containers (Formula A/B) and will be visually indistinguishable. Patients will receive gavage feeding every 3 hours, 7 times daily, for 12 days.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age 18–80 years, ICU admission with ≥72 hours of mechanical ventilation, legal consent or judicial approval, Enteral feeding possible within 48 hours, No participation in other interventional studies.
Exclusion criteria:
Pregnancy or lactation, Exclusive need for parenteral nutrition, History of liver cirrhosis or end-stage renal disease, Inability to tolerate enteral feeding, Intervention duration <4 days, Frequent transfusions or physician-determined ineligibility.
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Intervention groups
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Intervention: 2.2 g/kg of Karen's Iso Whey protein per day
Control: 1 g/kg of Karen's Iso Whey protein per day
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Main outcome variables
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60 days mortality
General information
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Reason for update
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Correction of trial information based on the latest protocol version
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180619040151N4
Registration date:
2019-11-07, 1398/08/16
Registration timing:
registered_while_recruiting
Last update:
2025-07-15, 1404/04/24
Update count:
1
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Registration date
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2019-11-07, 1398/08/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-10-11, 1398/07/19
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Expected recruitment end date
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2020-07-09, 1399/04/19
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Determination of the effect of high protein nutritional support in comparison to nutritional support with common protein in intensive care unit patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
18-80 years old
Patients who have been ventilated for at least the first 72 hours of admission
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.
ICU admission
Exclusion criteria:
Pregnant or lactation
Patients require only parenteral nutrition
History of diseases such as hepatocirrhosis and End-stage renal disease.
inability to tolerate EN
receipt of the study intervention for fewer than four days
frequent need for blood transfusions; or physician discretion deeming the patient unsuitable for participation.
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In the present study, both patients and outcome assessors will be blinded throughout the study.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-11, 1397/09/20
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1397.543
Health conditions studied
1
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Description of health condition studied
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Critical ill patients
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ICD-10 code
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Z00.01
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ICD-10 code description
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Encounter for general adult medical examination with abnormal findings
Primary outcomes
1
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Description
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mortality
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Timepoint
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mortality in the intensive care unit, days 28 and 60 after intaking protein
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Method of measurement
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If the patient is discharged from the intensive care unit, the patient will be contacted by telephone.
Secondary outcomes
1
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Description
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Nutrition Risk in the Critically Ill (NUTRIC) Score
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Timepoint
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Before intervention
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Method of measurement
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Nutrition Risk in the Critically Ill (NUTRIC) Score
2
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Description
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Acute Physiology and Chronic Health Evaluation (APACHE II) score changes
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Timepoint
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Before intervention
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Method of measurement
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Acute Physiology and Chronic Health Evaluation (APACHE II) score
3
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Description
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Sequential Organ Failure Assessment (SOFA) score
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Timepoint
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Before intervention, day 3, 5, 7, 9 and 11
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Method of measurement
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Sequential Organ Failure Assessment (SOFA) Score
4
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Description
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SARC-F Screen for Sarcopenia changes
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Timepoint
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Before intervention
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Method of measurement
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SARC-F Score
5
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Description
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Clinical Frailty Scale changes
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Timepoint
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Before intervention
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Method of measurement
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Clinical Frailty Scale score
Intervention groups
1
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Description
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The intervention group received 2.2 g/kg/day of Karen's Iso Whey protein via gavage feeding for 12 days. Surplus protein was primarily provided through enteral nutrition (BTF), with parenteral amino acids used only if enteral intake was insufficient.
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Category
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N/A
2
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Description
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Control group: 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 BTF is given to patients.)
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available