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

Primary Purpose

Intensive Care Unit Acquired Weakness

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Protein dose 1.5 g/kg/day
Protein dose 1.0 g/kg/day
Sponsored by
Spanish Society of Critical Care Medicine and Coronary Units
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intensive Care Unit Acquired Weakness focused on measuring Critically ill, Mechanical ventilation, Parenteral nutrition, Enteral nutrition, Protein dose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario Germans Trias i PujolRecruiting
  • Hospital Universitario de BellvitgeRecruiting
  • Hospital General Universitario de CastellónRecruiting
  • Hospital Universitario de BadajozRecruiting
  • Hospital de BarbastroRecruiting
  • Hospital Universitario de FuenlabradaRecruiting
  • Hospital Universitario Infanta CristinaRecruiting
  • Hospital de ManacorRecruiting
  • Hospital General Universitario Santa LucíaRecruiting
  • Hospital Clínico Universitario Virgen de la ArrixacaRecruiting
  • Hospital General Universitario Los Arcos del Mar MenorRecruiting
  • Hospital Universitario Doctor Josep TruetaRecruiting
  • Hospital Universitario Clínico San CecilioRecruiting
  • Hospital Universitario San JorgeRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital General Universitario Morales MeseguerRecruiting
  • Hospital Universitario Regional de MálagaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Protein dose 1.5 g/kg/day

Protein dose 1.0 g/kg/day

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Muscle Strength.
Dynamometry.
Active mobility.
Determined by Intensive Care Unit Mobility Scale (ICUMS). Scored from 0 to 10 being 0 no activity, lying in bed, and 10 walking independently without a gait aid.
Nosocomial infections.
Centers for disease control and prevention (CDC).
Mechanical ventilation.
Number of days receiving mechanical ventilation.
Gastrointestinal complications.
Gastric residual volume, diarrhea, vomiting or regurgitation, abdominal distension, constipation.
Metabolic complications.
Glycemia, fluid intake, electrolytes/trace element determination, hypertriglyceridemia, liver disfunction, cholestasis, necrosis or mixed dysfunction, overfeeding.
Mortality rate.
Length of ICU and hospital stay.
Number of days of hospitalization.
Quality of life index.
European Quality of Life-5 Dimensions (EQ-5D). Scored from 0 to 100 being 0 the worst health imaginable and 100 the best health imaginable.

Full Information

First Posted
May 30, 2023
Last Updated
June 15, 2023
Sponsor
Spanish Society of Critical Care Medicine and Coronary Units
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1. Study Identification

Unique Protocol Identification Number
NCT05918757
Brief Title
Efficacy and Safety of Administration of High Levels of Protein to Critically Ill Patients.
Acronym
FISIO
Official Title
Exploratory Study to Evaluate the Efficacy and Safety of Nutritional Administration of 1.5 g of Protein/kg/Day Versus 1.0 g of Protein/kg/Day in the Catabolic Phase of Critically Ill Patients Receiving Mechanical Ventilation.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spanish Society of Critical Care Medicine and Coronary Units

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care Unit Acquired Weakness
Keywords
Critically ill, Mechanical ventilation, Parenteral nutrition, Enteral nutrition, Protein dose

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Protein dose 1.5 g/kg/day
Arm Type
Experimental
Arm Description
Administration of 1.5 g of protein/kg/day in critically ill patients receiving invasive mechanical ventilation
Arm Title
Protein dose 1.0 g/kg/day
Arm Type
Active Comparator
Arm Description
Administration of 1.0 g of protein/kg/day in critically ill patients receiving invasive mechanical ventilation
Intervention Type
Other
Intervention Name(s)
Protein dose 1.5 g/kg/day
Intervention Description
Administration of 1.5 g of protein/kg/day via enteral/parenteral nutrition
Intervention Type
Other
Intervention Name(s)
Protein dose 1.0 g/kg/day
Intervention Description
Administration of 1.0 g of protein/kg/day via enteral/parenteral nutrition
Primary Outcome Measure Information:
Title
Change of intensive care unit acquired weakness (ICUAW).
Description
Determined by Medical Research Council sum score (MRC-SS). Diagnosis of ICUAW if MRC-SS < 48 (maximun score 60).
Time Frame
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 Outcome Measure Information:
Title
Muscle Strength.
Description
Dynamometry.
Time Frame
Up to 6 months.
Title
Active mobility.
Description
Determined by Intensive Care Unit Mobility Scale (ICUMS). Scored from 0 to 10 being 0 no activity, lying in bed, and 10 walking independently without a gait aid.
Time Frame
Up to 6 months.
Title
Nosocomial infections.
Description
Centers for disease control and prevention (CDC).
Time Frame
Throughout hospital stay, an expected average of 6 weeks.
Title
Mechanical ventilation.
Description
Number of days receiving mechanical ventilation.
Time Frame
Up to 1 month.
Title
Gastrointestinal complications.
Description
Gastric residual volume, diarrhea, vomiting or regurgitation, abdominal distension, constipation.
Time Frame
Throughout hospital stay, an expected average of 6 weeks.
Title
Metabolic complications.
Description
Glycemia, fluid intake, electrolytes/trace element determination, hypertriglyceridemia, liver disfunction, cholestasis, necrosis or mixed dysfunction, overfeeding.
Time Frame
Throughout hospital stay, an expected average of 6 weeks.
Title
Mortality rate.
Time Frame
Up to 6 months.
Title
Length of ICU and hospital stay.
Description
Number of days of hospitalization.
Time Frame
Throughout hospital stay, an expected average of 6 weeks.
Title
Quality of life index.
Description
European Quality of Life-5 Dimensions (EQ-5D). Scored from 0 to 100 being 0 the worst health imaginable and 100 the best health imaginable.
Time Frame
Up to 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María Carmen Sánchez Álvarez, PhD
Phone
+34915021213
Email
carmelasanchez757@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Francisco Fernández Ortega, PhD
Phone
+34951290000
Email
jfezortega@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María Carmen Sánchez Álvarez, PhD
Organizational Affiliation
Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan Francisco Fernández Ortega, PhD
Organizational Affiliation
Hospital Regional de Malaga
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luisa Bordejé Laguna, MD
Phone
+34934651200
Email
luisabordeje@gmail.com
First Name & Middle Initial & Last Name & Degree
Luisa Bordejé Laguna, MD
First Name & Middle Initial & Last Name & Degree
Esther Mor Marco, MD
Facility Name
Hospital Universitario de Bellvitge
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Manuel Gumicio Sanguino, MD
Phone
+34932607500
Email
vgumucio@bellvitgehospital.cat
First Name & Middle Initial & Last Name & Degree
Victor Manuel Gumicio Sanguino, MD
Facility Name
Hospital General Universitario de Castellón
City
Castelló de la Plana
State/Province
Castelló
ZIP/Postal Code
12004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Lidón Mateu Campos, MD
Phone
+34964725000
Email
lidonmateu@gmail.com
First Name & Middle Initial & Last Name & Degree
María Lidón Mateu Campos, MD
First Name & Middle Initial & Last Name & Degree
Fernando Sánchez Morán, MD
Facility Name
Hospital Universitario de Badajoz
City
Badajoz
State/Province
Extremadura
ZIP/Postal Code
06080
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariola Cerezo Arias, PhD
Phone
+34924218100
Email
mariolacerezo@yahoo.es
First Name & Middle Initial & Last Name & Degree
Mariola Cerezo Arias, PhD
First Name & Middle Initial & Last Name & Degree
María Dolores Pérez Frutos, PhD
First Name & Middle Initial & Last Name & Degree
Isabel María López Esteban, MD
Facility Name
Hospital de Barbastro
City
Barbastro
State/Province
Huesca
ZIP/Postal Code
22300
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos González Iglesias, MD
Phone
+34974249000
Email
cgisalamanca@hotmail.com
First Name & Middle Initial & Last Name & Degree
Carlos González Iglesias, MD
First Name & Middle Initial & Last Name & Degree
Mónica Zamora Elson, PhD
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clara Vaquerizo Alonso, MD
Phone
+34916006000
Email
clara.vaquerizo@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Clara Vaquerizo Alonso, MD
First Name & Middle Initial & Last Name & Degree
Gema Díaz Cuero, MD
First Name & Middle Initial & Last Name & Degree
Gema Candelaria Arellano del Verbo, MD
First Name & Middle Initial & Last Name & Degree
Paula Taboada Dominguez, MD
Facility Name
Hospital Universitario Infanta Cristina
City
Parla
State/Province
MAdrid
ZIP/Postal Code
28981
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belén Vila García, PhD
Phone
+34911913000
Email
belenvilag@yahoo.es
First Name & Middle Initial & Last Name & Degree
Belén Vila García, PhD
First Name & Middle Initial & Last Name & Degree
Marcela Homez Guzmán, MD
Facility Name
Hospital de Manacor
City
Manacor
State/Province
Mallorca
ZIP/Postal Code
07500
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Gastaldo Simeón, MD
Phone
+34971847000
Email
rousgastaldi@hotmail.com
First Name & Middle Initial & Last Name & Degree
Rosa Gastaldo Simeón, MD
First Name & Middle Initial & Last Name & Degree
Violeta Cano Collado, MD
Facility Name
Hospital General Universitario Santa Lucía
City
Cartagena
State/Province
Murcia
ZIP/Postal Code
30202
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
beatriz Perez Perez, PhD
Phone
+34968128600
Email
beatriz_perez5@hotmail.com
First Name & Middle Initial & Last Name & Degree
Beatriz Pérez Pérez, PhD
First Name & Middle Initial & Last Name & Degree
Angel Fernández Martínez, MD
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rubén Jara Rubio, MD
Phone
+34968369500
Email
rjarafibio@yahoo.es
First Name & Middle Initial & Last Name & Degree
Rubén Jara Rubio, MD
First Name & Middle Initial & Last Name & Degree
María Martínez Martínez, MD
First Name & Middle Initial & Last Name & Degree
María Ángeles Núñez Sánchez, PhD
First Name & Middle Initial & Last Name & Degree
Domingo Martínez Baños, MD
Facility Name
Hospital General Universitario Los Arcos del Mar Menor
City
Pozo Aledo
State/Province
Murcia
ZIP/Postal Code
30739
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuria Molina Sánchez, PhD
Phone
+34968565000
Email
nurihelen@gmail.com
First Name & Middle Initial & Last Name & Degree
Nuria Molina Sánchez, PhD
First Name & Middle Initial & Last Name & Degree
Francisco García Córdoba, MD
Facility Name
Hospital Universitario Doctor Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Lorencio Cárdenas, PhD
Phone
+34972940200
Email
carol_lorencio@hotmail.com
First Name & Middle Initial & Last Name & Degree
Carolina Lorencio Cárdenas, PhD
First Name & Middle Initial & Last Name & Degree
Meritxell Lladó Vilar, PhD
First Name & Middle Initial & Last Name & Degree
Neus Senyer Esquerra, MD
Facility Name
Hospital Universitario Clínico San Cecilio
City
Granada
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Colmenero Ruiz, PhD
Phone
+34958023000
Email
manuel.colmenero.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
Manuel Colmenero Ruiz, PhD
First Name & Middle Initial & Last Name & Degree
Josefina Moreno López, PhD
First Name & Middle Initial & Last Name & Degree
Jesús Giménez Gutiérrez, PhD
Facility Name
Hospital Universitario San Jorge
City
Huesca
ZIP/Postal Code
22004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Serón Arbeloa, MD
Phone
+34974247000
Email
cseron@unizar.es
First Name & Middle Initial & Last Name & Degree
Carlos Serón Arbeloa, MD
First Name & Middle Initial & Last Name & Degree
Alberto Lafita Pérez, PhD
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Luis Flordelis Lasierra, MD
Phone
+34913908000
Email
makalyconru@hotmail.com
First Name & Middle Initial & Last Name & Degree
José Luis Flordelis Lasierra, MD
First Name & Middle Initial & Last Name & Degree
Mónica Fuentes Ponte, MD
First Name & Middle Initial & Last Name & Degree
Helena Dominguez Aguado, MD
First Name & Middle Initial & Last Name & Degree
Laura Campos Bermejo, RN
First Name & Middle Initial & Last Name & Degree
Maria Luz Montero González, RN
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucía Cachafeiro Fuciños, PhD
Phone
+34917277000
Email
luciacachafeiro@yahoo.es
First Name & Middle Initial & Last Name & Degree
Lucía Cachafeiro Fuciños, PhD
First Name & Middle Initial & Last Name & Degree
Alexander Agrifolio Rotaeche, PhD
Facility Name
Hospital General Universitario Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maravillas de las Nieves Alcázar Espín, PhD
Phone
+34968360900
Email
mavialcazar@hotmail.com
First Name & Middle Initial & Last Name & Degree
Maravillas de las Nieves Alcázar Espín, PhD
First Name & Middle Initial & Last Name & Degree
Pilar Tornero Yepez, MD
Facility Name
Hospital Universitario Regional de Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Francisco Martínez Carmona, PhD
Phone
+34951290000
Email
jf.mtnez88@gmail.com
First Name & Middle Initial & Last Name & Degree
Juan Francisco Martínez Carmona, PhD
First Name & Middle Initial & Last Name & Degree
Juan Francisco Fernández Ortega, MD
First Name & Middle Initial & Last Name & Degree
Giulia Guidetti, MD
First Name & Middle Initial & Last Name & Degree
Rosa María Barraso González, MD
First Name & Middle Initial & Last Name & Degree
Ana Isabel Robles Rodríguez, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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