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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180619040151N4
Enrollment
60
Registered
2019-11-07
Start date
2019-10-11
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical ill patients. Encounter for general adult medical examination with abnormal findings

Interventions

Intervention 1: 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 pa

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Mortality. Timepoint: mortality in the intensive care unit, days 28 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

MeasureTime frame
Nutrition Risk in the Critically Ill (NUTRIC) Score. Timepoint: Before intervention. Method of measurement: Nutrition Risk in the Critically Ill (NUTRIC) Score.;Acute Physiology and Chronic Health Evaluation (APACHE II) score changes. Timepoint: Before intervention. Method of measurement: Acute Physiology and Chronic Health Evaluation (APACHE II) score.;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.;SARC-F Screen for Sarcopenia changes. Timepoint: Before intervention. Method of measurement: SARC-F Score.;Clinical Frailty Scale changes. Timepoint: Before intervention. Method of measurement: Clinical Frailty Scale score.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAbdolreza Norouzy

Mashhad University of Medical Sciences

norouzya@mums.ac.ir+98 51 3800 2382

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026