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

NCT ID: NCT05918757

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-06-30

Brief 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).

Detailed Description

It is known that protein metabolism is altered in critically ill patients due to metabolic alterations derived from stress. This critical situation is manifested by a severe catabolic alteration, especially in the first week, which is fundamentally characterized by severe glucose intolerance and the use of the protein itself as a metabolic substrate.

Despite protein synthesis is increased, this is insufficient to compensate for the high protein degradation rate, which leads, among others, to muscle deterioration resulting in increased morbidity and mortality. This muscle destruction has been implicated in the early appearance of Intensive care unit-acquired weakness (ICUAW). Although the pathophysiology of ICUAW is multifactorial, protein intake may play an key role in its treatment. However, protein intake cannot reduce muscle destruction, but it can stimulate protein synthesis.

Current evidence supports that the administration of early artificial nutritional support with a high protein intake can improve the clinical course of critically ill patients. However, there is still no consensus on the exact amount of protein needed to be administered to these patients in order to reduce adverse outcomes and prevent ICUAW.

Thus the aim of this study is to evaluate the effect of a nutritional supplementation containing 1.5 g of protein/kg/day vs 1.0 g of protein /kg/day in critically ill patients receiving mechanical ventilation on the development and degree of ICUAW.

Conditions

Intensive Care Unit Acquired Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Protein dose 1.5 g/kg/day

Administration of 1.5 g of protein/kg/day in critically ill patients receiving invasive mechanical ventilation

Group Type: EXPERIMENTAL

Protein dose 1.5 g/kg/day

Intervention Type: OTHER

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

Protein dose 1.0 g/kg/day

Administration of 1.0 g of protein/kg/day in critically ill patients receiving invasive mechanical ventilation

Group Type: ACTIVE_COMPARATOR

Protein dose 1.0 g/kg/day

Intervention Type: OTHER

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

Interventions

Protein dose 1.5 g/kg/day

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

Intervention Type: OTHER

Protein dose 1.0 g/kg/day

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Critically ill patient
• ICU admission during the previous 48h
• Patients on expected invasive mechanical ventilation for three days
• Patients with a minimum expected duration of clinical nutrition of at least seven days
• Written informed consent signed by the patient or the patient's legally authorized representative.
• Available central venous access for continuous infusion of the study drugs.

Exclusion Criteria

• Denied informed consent
• Acute renal failure (renal injury stage 3)
• Liver failure (cirrhosis or Child-Pugh Scale > 5)
• Severe liver failure with International Normalized Ratio (INR) > 1.7 (prothrombin time > 50%) and encephalopathy
• Patients with COVID-19-derived pneumonia
• Body Mass Index (BMI) > 40 or < 18.5 (morbid obesity or previous caloric malnutrition)
• Pregnant patients
• Central Nervous System pathologies (Glasgow < 6)
• Peripheral Nervous System pathologies interfering with study evaluations
• Patients with cognitive dysfunction/dementia or unable to follow instructions regarding MRC tests
• Severe muscular pathology
• Already participating in another clinical trial
• Impossibility to contact after ICU discharge to carry out the follow-up visit on day 90
• Known hypersensitivity to milk protein or any of the components of the nutritional supplement
• Inborn errors in the amino acid metabolism
• Previous inclusion in the present study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Society of Critical Care Medicine and Coronary Units

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

María Carmen Sánchez Álvarez, PhD

Role: PRINCIPAL_INVESTIGATOR

Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)

Juan Francisco Fernández Ortega, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Regional de Malaga

Locations

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital General Universitario de Castellón

Castellon, Castelló, Spain

Hospital Universitario de Badajoz

Badajoz, Extremadura, Spain

Hospital de Barbastro

Barbastro, Huesca, Spain

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

Hospital Universitario Infanta Cristina

Parla, Madrid, Spain

Hospital de Manacor

Manacor, Mallorca, Spain

Hospital General Universitario Santa Lucía

Cartagena, Murcia, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital General Universitario Los Arcos del Mar Menor

Pozo-Aledo, Murcia, Spain

Hospital Universitario Doctor Josep Trueta

Girona, , Spain

Hospital Universitario Clínico San Cecilio

Granada, , Spain

Hospital Universitario San Jorge

Huesca, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario Regional de Málaga

Málaga, , Spain

Hospital General Universitario Morales Meseguer

Murcia, , Spain

Countries

Spain

Other Identifiers

2021-002329-56

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ASF1

Identifier Type: -

Identifier Source: org_study_id