IRCT20180619040151N4
Recruiting
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Critical ill patients.
- Sponsor
- Mashhad University of Medical Sciences
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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