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High Protein Intake and Early Exercise in Adult Intensive Care Patients

High Protein Intake and Early Exercise in Adult Intensive Care Patients: Impact on Functional Outcomes. A Randomized Controlled Phase II Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03469882
Enrollment
180
Registered
2018-03-19
Start date
2018-06-01
Completion date
2020-07-31
Last updated
2021-07-30

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

Conditions

Critically Ill Patients

Keywords

Protein, exercise, critical illness, outcome,

Brief summary

This study analyse the impact of high protein intake associated to early programed exercise on functional outcomes of adult intensive care patients.

Detailed description

The muscle weakness associated to intensive care, one of the components of Post Intensive Care Syndrome (PICS) has a significant impact on the short-term and long-term outcomes in the critically ill patient (1, 2). Puthucheary et al. (3) analyzed 63 septic patients with imaging examination and established a clear relationship between the number of organ failures and muscle loss in the first 10 days of ICU. Although a study involving 244 critically ill patients has shown an alarming relationship between reduced muscle mass at admission and mortality (4), evidences that nutritional interventions can attenuate muscle loss and result in improvement in outcome are unclear. Recent studies evaluating the impact of nutritional therapy on clinical outcomes have surprisingly demonstrated that patients who received full nutritional intake did not differ in outcomes when compared to those receiving reduced nutritional intake, the so-called permissive underfeeding (5, 6, 7). Careful analysis of these studies, however, reveals that the authors define hyponutrition as synonymous with reduced calorie intake, without mentioning the protein intake offered to the patients. The study with the greatest scientific repercussion (8) used reduced caloric intake in the study group, but the protein intake did not differ between groups. Observational studies comparing high protein intake with conventional intake have shown improvement in outcome indicators in patients receiving more than 1.6 and even more than 2.0 g / kg / day of protein (9, 10). Recently the intensive care medicine research agenda published in the journal of the European Society of Intensive Care Medicine, the top priority of the nutrition research in the critically ill patients was to compare normal and hyperproteic nutrition ideally associated with physical activity (11). Several recent studies have shown benefits of early physical rehabilitation in the critically ill patient (12, 13). The optimal integration between adequate protein intake and exercise in the critically ill patient may have an impact on short- and long-term outcomes, but this hypothesis has not yet been tested by studies with a good methodology. The hypothesis of this prospective randomized phase II study is that the association of high protein intake with early physical rehabilitation improves physical function after hospital discharge with a significant impact on quality of life.

Interventions

DIETARY_SUPPLEMENTHigh protein nutrition

Patients in the HPE group will be submitted to nutritional support preferably through the enteral route. Energy expenditure will be determined by indirect calorimetry. They will receive 2.0 to 2.2 grams/kg/day of protein.

DEVICECycle ergometry exercise

Patients will be submitted to two daily sessions of exercise (cycle ergometry) 15 minutes duration each, during the 7 days of the week. The intervention will be maintained exclusively duting the patient's stay in the ICU. The cycle ergometer will be the MotoMed Letto II (Reck Technik, Germany).

OTHERUsual care group

Participants randomized to the usual care group will receive usual care protein and exercise.

Sponsors

Hospital Sao Domingos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Blinded outcomes assessment

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

We will include 180 consecutive patients admitted to one of the study ICUs * Aged 18 years or above. * Non-pregnant. * Requiring mechanical ventilation for at least 48 hours. * Expected ICU stay higher than 3 days.

Exclusion criteria

* Inability to walk without assistance before the acute illness that led to ICU admission (use of gait aid is not an exclusion criterion). * Cognitive impairment prior to hospitalization described by relatives and evaluated by the ICU psychology team. * Neuromuscular diseases that compromise weaning from mechanical ventilation. * Acute pelvic fracture. * Unstable spinal cord trauma. * Patients considered moribund. * In some situations patients will not be included in the resistive exercise program for as long as a temporary limiting factor remains: * Patients undergoing neuromuscular blocking drugs. * Patients under high-dose vasoactive drug use. * Mechanical ventilation with FIO2 (fraction of inspired oxygen) ≥ 60% and / or PEEP (positive end-expiratory pressure)\> 12 cm H2O. * Intracranial hypertension. * . Open abdomen. * Status epilepticus.

Design outcomes

Primary

MeasureTime frameDescription
Physical component summary (PCS) 3 months after randomization3 months after randomizationBlind assessment of PCS after 3 months after randomization
Physical component summary (PCS) 6 months after randomization6 months after randomizationBlind assessment of PCS after 6 months after randomization

Secondary

MeasureTime frameDescription
handgrip strength20 dayshandgrip strength measured at ICU discharge,
Duration of mechanical ventilation20 daysLength of time under mechanical ventilation
Length of ICU stay20 daysLength of ICU stay
Hospital mortality6 monthsHospital mortality

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026