Determination of the effect of high protein nutritional support in comparison to nutritional support with common protein in intensive care unit patients

Phase 3

Recruiting

• Conditions: Critical ill patients.; Encounter for general adult medical examination with abnormal findings; Z00.01

• Registration Number: IRCT20180619040151N4
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 December 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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
Pregnant
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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality. Timepoint: mortality in the intensive care unit and days 12 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 Outcome Measures

Name	Time	Method
utrition Risk in the Critically Ill (NUTRIC) Score. Timepoint: Before intervention, day 7 and 12. Method of measurement: Nutrition Risk in the Critically Ill (NUTRIC) Score.;Acute Physiology and Chronic Health Evaluation (APACHE II) score changes. Timepoint: Before intervention, day 7 and 12. 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, day 12. Method of measurement: SARC-F Score.;Clinical Frailty Scale changes. Timepoint: Before intervention, day 12. Method of measurement: Clinical Frailty Scale score.