Exploratory study to evaluate the efficacy and safety of nutritionally administering 1.5 g protein/kg/day vs. 1.0 g protein/kg/day in the catabolic phase of the critically ill patient on mechanical ventilation

Exploratory study to evaluate the efficacy and safety of nutritionally administering 1.5 g protein/kg/day vs. 1.0 g protein/kg/day in the catabolic phase of the critically ill patient on mechanical ventilation. - efficacy and safety of administering elevated levels of prOteins to critically ill patients prOteins

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002329-56-ES

Enrollment

200

Registered

2021-06-25

Start date

2021-10-19

Completion date

Unknown

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Weakness in the Intensive Care Unit (DAUCI) of the critically ill patient. MedDRA version: 20.0 Level: PT Classification code 10077255 Term: Intensive care unit acquired weakness System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: SmofKaviben Central Product Name: SmofKaviben Central Pharmaceutical Form: Emulsion for infusion INN or Proposed INN: ALANINE CAS Number: 56-41-7 Current Sponsor code: ALANINE Other descri

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Must meet all criteria for inclusion: 1. Critically ill patient, adult > 18 years of age. 2. Admission to the ICU during the previous 48 hours. 3. Patients on invasive mechanical ventilation with a minimum expected duration of > 3 days. 4. Patient with a minimum expected duration of clinical nutrition of > 7 days from 48 hours after admission. 5. Written informed consent from the patient or the patient's legal representative or deferred written consent from the patient or the patient's legal representative. 6. Central venous access available for continuous infusion of study drugs. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: 1. Refusal of informed consent 2. Acute renal failure (renal injury stage of 3) 3. Hepatic failure (cirrhosis or Chilg-Pugh Scale > 5). 4. Severe hepatic insufficiency with INR > 1.7 (prothrombin time 40 or < 18.5 (morbid obesity or previous caloric malnutrition) 7. Pregnant patients 8. CNS pathologies (Glasgow < 6) 9. Peripheral SN pathologies 10. Patients with cognitive dysfunction/dementia or unable to follow instructions regarding MRC tests. 11. Severe muscular pathology 12. Participation in another clinical trial 13. Usual residence outside the region (impossibility of contact after discharge from the ICU). 14. Known hypersensitivity to milk protein or to any substance contained in Fresubin®. 15. Any congenital error in the metabolism of amino acids. 16. Previous inclusion in the present study

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the occurrence and degree of Acquired Acute Critical Care Unit Weakness (ICUCI or ICUAW) in 2 groups of patients treated with different doses of protein (1.5.g/kg/day vs. 1.0 g/kg/day).;Secondary Objective: To compare the rate of: - Infectious complications appeared in each of the two groups. - Days of mechanical ventilation - Metabolic and/or gastrointestinal complications - Intra-ICU, in-hospital, 30 and 90 day mortality - Intra-ICU and hospital days - Urinary nitrogen excretion during time in ICU - Quality of life at hospital discharge and 90 days;Primary end point(s): The primary endpoint will be Intensive Care Unit-Acquired Acute Care Weakness (ICUAW) as defined by a Medical Research Council (MRC Scale) score of less than 48, measured from ventilator weaning, every 4-6 days, on day 28 or at ICU discharge. (ANNEXES 4 and 4a);Timepoint(s) of evaluation of this end point: Every 4-6 days, on day 28 or at ICU discharge.	—

Measure

Time frame

Main Objective: To compare the occurrence and degree of Acquired Acute Critical Care Unit Weakness (ICUCI or ICUAW) in 2 groups of patients treated with different doses of protein (1.5.g/kg/day vs. 1.0 g/kg/day).;Secondary Objective: To compare the rate of: - Infectious complications appeared in each of the two groups. - Days of mechanical ventilation - Metabolic and/or gastrointestinal complications - Intra-ICU, in-hospital, 30 and 90 day mortality - Intra-ICU and hospital days - Urinary nitrogen excretion during time in ICU - Quality of life at hospital discharge and 90 days;Primary end point(s): The primary endpoint will be Intensive Care Unit-Acquired Acute Care Weakness (ICUAW) as defined by a Medical Research Council (MRC Scale) score of less than 48, measured from ventilator weaning, every 4-6 days, on day 28 or at ICU discharge. (ANNEXES 4 and 4a);Timepoint(s) of evaluation of this end point: Every 4-6 days, on day 28 or at ICU discharge.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary objectives will be studied by: - Muscle strength will be measured by Dynamometry ICU, Hospital and at 90 days, and mobility will be measured by IMS (Intensive Mobility Scale) at ICU discharge, hospital discharge and at 90 days. (ANNEX 5) - Incidence of new nosocomial infections (as defined by the Centers for Disease Control and Prevention (CDC). (ANNEX 6) - Surgical wound infection - Primary bacteremia - Cardiovascular system infection - Central nervous system infection - Gastrointestinal Tract Infection - Skin and soft tissue infection - Pneumonia associated with mechanical ventilation - Lower respiratory tract infection without evidence of pneumonia (tracheobronchitis) - Urinary tract infection - Sinusitis - Duration and type of infection. (Onset and end) - Days of mechanical ventilation - ICU and hospital stay days - Mortality (ICU, hospital, 90 days);Timepoint(s) of evaluation of this end point: At ICU discharge, hospital discharge and at 90 days.	—

Measure

Time frame

Secondary end point(s): Secondary objectives will be studied by: - Muscle strength will be measured by Dynamometry ICU, Hospital and at 90 days, and mobility will be measured by IMS (Intensive Mobility Scale) at ICU discharge, hospital discharge and at 90 days. (ANNEX 5) - Incidence of new nosocomial infections (as defined by the Centers for Disease Control and Prevention (CDC). (ANNEX 6) - Surgical wound infection - Primary bacteremia - Cardiovascular system infection - Central nervous system infection - Gastrointestinal Tract Infection - Skin and soft tissue infection - Pneumonia associated with mechanical ventilation - Lower respiratory tract infection without evidence of pneumonia (tracheobronchitis) - Urinary tract infection - Sinusitis - Duration and type of infection. (Onset and end) - Days of mechanical ventilation - ICU and hospital stay days - Mortality (ICU, hospital, 90 days);Timepoint(s) of evaluation of this end point: At ICU discharge, hospital discharge and at 90 days.

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Countries

Spain

Contacts

Public ContactMaría del Carmen Sánchez Álvarez

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

secretaria@semicyuc.org34915021213

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026