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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Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Abdolreza Norouzy
Full name of responsible person - Persian: عبدالرضا نوروزی
Position - English: Associate professor
Position - Persian: دانشیار-پزشک متخصص هیئت علمی
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Hemmat Highway, next to Milad Tower, Iran University of Medical Sciences
Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 14496-14535
Phone: +98 21 86701
Mobile: +98 21 86701
Fax:
Email: Norouzy@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Pardis Irandoost
Full name of responsible person - Persian: پردیس ایراندوست
Position - English: Assistant professor
Position - Persian: استادیار و هیئت علمی
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Hemmat Highway, next to Milad Tower, Iran University of Medical Sciences
Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 14496-14535
Phone: +98 21 86701
Mobile: +98 21 86701
Fax:
Email: pardis_irandoost@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Abdolreza NorouzyPardis Irandoost Full name of responsible person - Persian: عبدالرضا نوروزیپردیس ایراندوست Position - English: AssociateAssistant professor Position - Persian: دانشیار-پزشک متخصصاستادیار و هیئت علمی Latest degree: phd Area of specialty/work: 34 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Hemmat Highway, next to Milad Tower, Iran University of Medical Sciences Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 14496-14535 Phone: +98 21 86701 Mobile: +98 21 86701 Fax: Email: Norouzypardis_irandoost@gmail.comyahoo.com Web page address:
Protocol summary
Study aim
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.
Design
88 critically ill patients will be divided into two groups of 44: intervention and control, using a randomized block design.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
(1.6 g/kg/day) in the intervention group and (1.2 g/kg/day) in the control group
Main outcome variables
Zonulin levels and intestinal permeability; APACHE II questionnaire; SFOA questionnaire; NUTRIC questionnaire; 30-day and 60-day mortality
General information
Reason for update
Acronym
IRCT registration information
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
Registration date
2024-12-11, 1403/09/21
Registrant information
Name
Shonaz Ahmadikhatir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2359
Email address
sh_khatir@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-02, 1403/12/12
Expected recruitment end date
2025-09-21, 1404/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
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.
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Random permutation blocks
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, principal investigator, healthcare providers
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
Shahid Fakouri Blvd, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2024-11-17, 1403/08/27
Ethics committee reference number
IR.MUMS.REC.1403.298
Health conditions studied
1
Description of health condition studied
critically ill patients admitted to the intensive care units
ICD-10 code
R69
ICD-10 code description
Illness, unspecified
Primary outcomes
1
Description
Zonulin levels and intestinal permeability are increased in critically ill patients.
Timepoint
zonulin levels will be assessed before the start of the intervention and on days 5 and 10.
Method of measurement
Zonulin (ng/mL) will be measured from serum samples using a human zonulin ELISA kit with a sandwich ELISA method.
2
Description
Mortality
Timepoint
SOFA Questionnaire
Method of measurement
Every other day - Scores range from 0 to 24 - higher values indicate organ dysfunction and a poor prognosis.
3
Description
Disease Severity
Timepoint
APACHE questionnaire
Method of measurement
first day of admission - score between 1 and 71 - score above 34 show 85% mortality
4
Description
Nutritional risk assessment
Timepoint
The first 24 hours after admission to the ICU
Method of measurement
mNUTRIC score - 0 to 9 points - scores ≥4 indicate nutritional risk and are considered high risk and scores <4 indicate low nutritional risk