Protocol summary
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Study aim
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Effect of high-dose protein compared to conventional protein on intestinal permeability, disease severity, and mortality in critically ill patients admitted to the intensive care units.
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Design
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88 critically ill patients will be divided into two groups of 44: intervention and control, using a randomized block design.
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Settings and conduct
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The study subjects will be selected from 88 critically ill patients at Hazrat Rasoul Akram Hospital in Tehran. The intervention group will receive enteral nutrition with high protein content (1.6 g/kg/day) and the control group will receive enteral nutrition with normal protein content (1.2 g/kg/day). During the intervention, zenulin levels will be assessed on days 0, 5, and 10. The SOFA, APACHE II, and NUTRIC questionnaires will also be assessed. Mortality rates will be calculated at 30 days and 60 days from the start of the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1- ages 18 to 65 (both sexes)
2- At least 24 hours have passed since admission to the intensive care unit.
3- At least 1 day has passed since the patient received enteral feeding.
4- The patient is stable in hemodynamics.
5- At least 60% of the protein intake is provided by enteral feeding.
6- Willingness to cooperate and sign the informed consent
Exclusion criteria:
1- Death or discharge before 4th day
2-Consuming glutamine supplementation
3- NPO more than 4 days
4- Contraindication to EN
5- Unwillingness to cooperate in the project
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Intervention groups
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(1.6 g/kg/day) in the intervention group and (1.2 g/kg/day) in the control group
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Main outcome variables
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Zonulin levels and intestinal permeability; APACHE II questionnaire; SFOA questionnaire; NUTRIC questionnaire; 30-day and 60-day mortality
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20241129063891N1
Registration date:
2024-12-11, 1403/09/21
Registration timing:
prospective
Last update:
2025-07-11, 1404/04/20
Update count:
1
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Registration date
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2024-12-11, 1403/09/21
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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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2025-03-02, 1403/12/12
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Expected recruitment end date
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2025-09-21, 1404/06/30
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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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Effect of high-dose protein compared to conventional protein on intestinal permeability, disease severity, and mortality in critically ill patients admitted to the intensive care units.
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Public title
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Effect of high-dose protein compared to conventional protein on intestinal permeability, disease severity, and mortality in critically ill patients admitted to the intensive care units.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Ages 18 to 65 (both sexes)
At least 24 hours have passed since admission to the intensive care unit.
At least 1 day has passed since the patient received enteral feeding.
The patient is stable in hemodynamics
At least 60% of the protein intake is provided by enteral feeding.
Willingness to cooperate and sign the informed consent.
Exclusion criteria:
Death or discharge before 4th day
consuming Glutamine supplementation
NPO more than 4 days
Contraindication to EN
Unwillingness to cooperate in the project
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Age
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From 18 years old to 65 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
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
88
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random permutation blocks
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, principal investigator, healthcare providers
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Placebo
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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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2024-11-17, 1403/08/27
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Ethics committee reference number
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IR.MUMS.REC.1403.298
Health conditions studied
1
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Description of health condition studied
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critically ill patients admitted to the intensive care units
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ICD-10 code
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R69
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ICD-10 code description
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Illness, unspecified
Primary outcomes
1
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Description
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Zonulin levels and intestinal permeability are increased in critically ill patients.
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Timepoint
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zonulin levels will be assessed before the start of the intervention and on days 5 and 10.
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Method of measurement
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Zonulin (ng/mL) will be measured from serum samples using a human zonulin ELISA kit with a sandwich ELISA method.
2
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Description
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Mortality
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Timepoint
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SOFA Questionnaire
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Method of measurement
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Every other day - Scores range from 0 to 24 - higher values indicate organ dysfunction and a poor prognosis.
3
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Description
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Disease Severity
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Timepoint
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APACHE questionnaire
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Method of measurement
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first day of admission - score between 1 and 71 - score above 34 show 85% mortality
4
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Description
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Nutritional risk assessment
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Timepoint
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The first 24 hours after admission to the ICU
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Method of measurement
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mNUTRIC score - 0 to 9 points - scores ≥4 indicate nutritional risk and are considered high risk and scores <4 indicate low nutritional risk
Intervention groups
1
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Description
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Intervention group: High-protein enteral nutrition (1.6 g/kg/day)
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Category
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Treatment - Other
2
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Description
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Control group: Enteral nutrition with conventional protein intake (1.2 g/kg/day)
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Category
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Other
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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be 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