Intensive Care Unit Acquired WeaknessFISIONCT05918757
Efficacy and Safety of Administration of High Levels of Protein to Critically Ill Patients.
A study testing Protein dose 1.5 g/kg/day and Protein dose 1.0 g/kg/day in people with Intensive Care Unit Acquired Weakness, run by Spanish Society of Critical Care Medicine and Coronary Units at 18 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Acquired Weakness
- What is being tested?
- Protein dose 1.5 g/kg/day and Protein dose 1.0 g/kg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 18 sitesSpain
- Study dates
- 1 Jan 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Spain18 sites
Hospital Universitario de Badajoz
Badajoz, Extremadura, 06080
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital de Barbastro
Barbastro, Huesca, 22300
Hospital General Universitario Santa Lucía
Cartagena, Murcia, 30202
Hospital General Universitario de Castellón
Castellon, Castelló, 12004
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942
Hospital Universitario Doctor Josep Trueta
Girona, 17007
Hospital Universitario Clínico San Cecilio
Granada, 18016
Hospital Universitario San Jorge
Huesca, 22004
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Regional de Málaga
Málaga, 29010
Hospital de Manacor
Manacor, Mallorca, 07500
Hospital General Universitario Morales Meseguer
Murcia, 30008
Hospital Universitario Infanta Cristina
Parla, Madrid, 28981
Hospital General Universitario Los Arcos del Mar Menor
Pozo-Aledo, Murcia, 30739
About this study
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.
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).
Read the 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
- Being tested
- Protein dose 1.5 g/kg/day, Protein dose 1.0 g/kg/day
- Keywords
- Critically ill, Mechanical ventilation, Parenteral nutrition, Enteral nutrition, Protein dose
- Medical subject headings
- Critical Illness, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein dose 1.5 g/kg/dayOther
Administration of 1.5 g of protein/kg/day via enteral/parenteral nutrition
Protein dose 1.0 g/kg/dayOther
Administration of 1.0 g of protein/kg/day via enteral/parenteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Protein dose 1.0 g/kg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Dynamometry.
Measured: Up to 6 months.
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.
Measured: Up to 6 months.
Nosocomial infections.
Centers for disease control and prevention (CDC).
Measured: Throughout hospital stay, an expected average of 6 weeks.
Mechanical ventilation.
Number of days receiving mechanical ventilation.
Measured: Up to 1 month.
Gastrointestinal complications.
Gastric residual volume, diarrhea, vomiting or regurgitation, abdominal distension, constipation.
Measured: Throughout hospital stay, an expected average of 6 weeks.
Metabolic complications.
Glycemia, fluid intake, electrolytes/trace element determination, hypertriglyceridemia, liver disfunction, cholestasis, necrosis or mixed dysfunction, overfeeding.
Measured: Throughout hospital stay, an expected average of 6 weeks.
Mortality rate.
Number of deaths/total participants
Measured: Up to 6 months.
Length of ICU and hospital stay.
Number of days of hospitalization.
Measured: Throughout hospital stay, an expected average of 6 weeks.
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.
Measured: Up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Jan 2022
- Primary completion31 Mar 2024
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit Acquired WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spanish Society of Critical Care Medicine and Coronary Units
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- María Carmen Sánchez Álvarez, PhD, Principal investigator, Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)Juan Francisco Fernández Ortega, PhD, Principal investigator, Hospital Regional de Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918757
- Sponsor's protocol ID
- ASF1
- Other IDs
- 2021-002329-56
- Acronym
- FISIO
- Status last verified
- Jun 2024
- First submitted
- 30 May 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05918757
- Acronym / sponsor ID
- FISIO / ASF1
- Conditions
- Intensive Care Unit Acquired Weakness
- Keywords
- Critically ill, Mechanical ventilation, Parenteral nutrition, Enteral nutrition, Protein dose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Spanish Society of Critical Care Medicine and Coronary UnitsUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Protein dose 1.5 g/kg/day | Experimental | Other: Protein dose 1.5 g/kg/dayAdministration of 1.5 g of protein/kg/day in critically ill patients receiving invasive mechanical ventilation |
| Protein dose 1.0 g/kg/day | Active comparator | Other: Protein dose 1.0 g/kg/dayAdministration of 1.0 g of protein/kg/day in critically ill patients receiving invasive mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein dose 1.5 g/kg/dayAdministration of 1.5 g of protein/kg/day via enteral/parenteral nutrition | Other | Protein dose 1.5 g/kg/day |
| Protein dose 1.0 g/kg/dayAdministration of 1.0 g of protein/kg/day via enteral/parenteral nutrition | Other | Protein dose 1.0 g/kg/day |
Primary outcome
Change of intensive care unit acquired weakness (ICUAW).
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.
Determined by Medical Research Council sum score (MRC-SS). Diagnosis of ICUAW if MRC-SS < 48 (maximun score 60).
9 secondary outcomes
Muscle Strength.
Time frame: Up to 6 months.
Active mobility.
Time frame: Up to 6 months.
Nosocomial infections.
Time frame: Throughout hospital stay, an expected average of 6 weeks.
Mechanical ventilation.
Time frame: Up to 1 month.
Gastrointestinal complications.
Time frame: Throughout hospital stay, an expected average of 6 weeks.
Metabolic complications.
Time frame: Throughout hospital stay, an expected average of 6 weeks.
Mortality rate.
Time frame: Up to 6 months.
Length of ICU and hospital stay.
Time frame: Throughout hospital stay, an expected average of 6 weeks.
Quality of life index.
Time frame: Up to 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Carmen Sánchez Álvarez, PhD principal investigator
Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)
Juan Francisco Fernández Ortega, PhD principal investigator
Hospital Regional de Malaga
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein dose 1.5 g/kg/day and Protein dose 1.0 g/kg/day in people with Intensive Care Unit Acquired Weakness, run by Spanish Society of Critical Care Medicine and Coronary Units at 18 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of intensive care unit acquired weakness (ICUAW). (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.