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Efficacy and Safety of Administration of High Levels of Protein to Critically Ill Patients.

NCT05918757 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-06-20

No results posted yet for this study

Summary

Critically ill patients are known to develop serious nutritional deterioration during the course of their disease. They develop, from the beginning, a multifactorial protein malnutrition that relates to a poor clinical course and the development of weakness. Due to the increased protein catabolism in this type of patient, there is a rapid degradation of muscle mass and loss of functional proteins, and therefore nutritional support is mandatory. Indeed, achieving a high protein intake may promote a better evolution of the critically ill patient, i.e., maintenance of muscle protein, less deterioration of muscle strength, lower Intensive care unit-acquired weakness (ICUAW), lower mortality, decrease in the number of infections, decrease in days on mechanical ventilation, and days of hospital stay and in ICU.

The goal of this clinical trial is to compare the appearance and degree of ICUAW in critically ill patients receiving invasive mechanical ventilation treated with two different doses of protein (1.5 g/kg/day vs.1.0 g/kg/day).

Conditions

  • Intensive Care Unit Acquired Weakness

Interventions

OTHER

Protein dose 1.5 g/kg/day

Administration of 1.5 g of protein/kg/day via enteral/parenteral nutrition

OTHER

Protein dose 1.0 g/kg/day

Administration of 1.0 g of protein/kg/day via enteral/parenteral nutrition

Sponsors & Collaborators

  • Spanish Society of Critical Care Medicine and Coronary Units

    lead OTHER

Principal Investigators

  • María Carmen Sánchez Álvarez, PhD · Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)

  • Juan Francisco Fernández Ortega, PhD · Hospital Regional de Malaga

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-03-31
Completion
2024-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05918757 on ClinicalTrials.gov