Skip to main content
Clinical Trials/IRCT20180619040151N4
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

Mashhad University of Medical Sciences0 sites60 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

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

Similar Trials