An interventional study of High protein nutrition and Cycle ergometry exercise in Critically Ill Patients, sponsored by Hospital Sao Domingos. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-30.
Sponsored by Hospital Sao Domingos · Not applicable, Interventional, and Treatment
This study analyse the impact of high protein intake associated to early programed exercise on functional outcomes of adult intensive care patients.
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.
We will include 180 consecutive patients admitted to one of the study ICUs
Exclusion Criteria:
Begining within 48 hours of ICU admission participants will receive nutrition support with energy expenditure measured by indirect calorimetry, 2.0 to 2.2 g/kg/day of protein and in-bed cycle ergometry exercise.
Dietary Supplement: High protein nutrition · Device: Cycle ergometry exercise
Participants randomized to the usual care group will receive usual care protein and exercise
Other: Usual care group
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.
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).
Participants randomized to the usual care group will receive usual care protein and exercise.
Also known as: No intervention
Physical component summary (PCS) 3 months after randomization
Blind assessment of PCS after 3 months after randomization
Time frame: 3 months after randomization
Physical component summary (PCS) 6 months after randomization
Blind assessment of PCS after 6 months after randomization
Time frame: 6 months after randomization
handgrip strength
handgrip strength measured at ICU discharge,
Time frame: 20 days
Duration of mechanical ventilation
Length of time under mechanical ventilation
Time frame: 20 days
Length of ICU stay
Length of ICU stay
Time frame: 20 days
Hospital mortality
Hospital mortality
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Hospital Sao Domingos