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

NCT05918757 | Active Not Recruiting DMC

• 2 other identifiers: ASF12021-002329-56
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 18

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).

Conditions

Intensive Care Unit Acquired Weakness

Keywords

Critically ill; Mechanical ventilation; Parenteral nutrition; Enteral nutrition; Protein dose

Outcome Measures

Primary Outcomes (1)

• Change of intensive care unit acquired weakness (ICUAW).

  Determined by Medical Research Council sum score (MRC-SS). Diagnosis of ICUAW if MRC-SS \< 48 (maximun score 60).

  Baseline, weekly in ICU up to 28 days after mechanical ventilation termination, throughout hospital stay, an expected average of 6 weeks, and 90 days after hospital discharge.

Secondary Outcomes (9)

• Muscle Strength.

  Up to 6 months.

• Active mobility.

  Up to 6 months.

• Nosocomial infections.

  Throughout hospital stay, an expected average of 6 weeks.

• Mechanical ventilation.

  Up to 1 month.

• Gastrointestinal complications.

  Throughout hospital stay, an expected average of 6 weeks.

Study Arms (2)

Protein dose 1.5 g/kg/day

EXPERIMENTAL

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

Other: Protein dose 1.5 g/kg/day

Protein dose 1.0 g/kg/day

ACTIVE COMPARATOR

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

Other: Protein dose 1.0 g/kg/day

Interventions

Protein dose 1.5 g/kg/day OTHER

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

Protein dose 1.5 g/kg/day

Protein dose 1.0 g/kg/day OTHER

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

Protein dose 1.0 g/kg/day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Spanish Society of Critical Care Medicine and Coronary Units: lead

Study Sites (18)

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital General Universitario de Castellón

Castellon, Castelló, 12004, Spain

Location

Hospital Universitario de Badajoz

Badajoz, Extremadura, 06080, Spain

Location

Hospital de Barbastro

Barbastro, Huesca, 22300, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

Hospital Universitario Infanta Cristina

Parla, Madrid, 28981, Spain

Location

Hospital de Manacor

Manacor, Mallorca, 07500, Spain

Location

Hospital General Universitario Santa Lucía

Cartagena, Murcia, 30202, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital General Universitario Los Arcos del Mar Menor

Pozo-Aledo, Murcia, 30739, Spain

Location

Hospital Universitario Doctor Josep Trueta

Girona, 17007, Spain

Location

Hospital Universitario Clínico San Cecilio

Granada, 18016, Spain

Location

Hospital Universitario San Jorge

Huesca, 22004, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Regional de Málaga

Málaga, 29010, Spain

Location

Hospital General Universitario Morales Meseguer

Murcia, 30008, Spain

Location

MeSH Terms

Conditions

Critical Illness; Hyperphagia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• María Carmen Sánchez Álvarez, PhD

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

  PRINCIPAL INVESTIGATOR

• Juan Francisco Fernández Ortega, PhD

  Hospital Regional de Malaga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within 48 hours, intensive care patients on expected invasive mechanical ventilation of at least three days are allocated into two groups receiving enteral/parenteral nutrition with 1.5 g of protein/kg/day or 1.0 g of protein/kg/day as an active comparator.

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 26, 2023
• Study Start: January 1, 2022
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (18)