High Protein Intake and Early Exercise in Adult Intensive Care Patients
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|ClinicalTrials.gov Identifier: NCT03469882|
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : May 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Critically Ill Patients||Dietary Supplement: High protein nutrition Device: Cycle ergometry exercise Other: Usual care group||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Randomized controlled phase 2 study|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Blinded outcomes assessment|
|Official Title:||High Protein Intake and Early Exercise in Adult Intensive Care Patients: Impact on Functional Outcomes. A Randomized Controlled Phase II Trial.|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||July 31, 2020|
Experimental: High protein and exercise (HPE) group
Begining within 48 hours of ICU admission participants will receive nutrition support with energy expenditure measured by indirect calorimetry, 2.0 to 2.5 g/kg/day of protein and in-bed cycle ergometry exercise.
Dietary Supplement: High 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 2.5 grams/kg/day of protein.
Device: Cycle 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).
Usual care group
Participants randomized to the usual care group will receive usual care protein and exercise
Other: Usual care group
Participants randomized to the usual care group will receive usual care protein and exercise.
Other Name: No intervention
- Physical component summary (PCS) 3 months after randomization [ Time Frame: 3 months after randomization ]Blind assessment of PCS after 3 months after randomization
- Physical component summary (PCS) 6 months after randomization [ Time Frame: 6 months after randomization ]Blind assessment of PCS after 6 months after randomization
- handgrip strength [ Time Frame: 20 days ]handgrip strength measured at ICU discharge,
- Duration of mechanical ventilation [ Time Frame: 20 days ]Length of time under mechanical ventilation
- Length of ICU stay [ Time Frame: 20 days ]Length of ICU stay
- Hospital mortality [ Time Frame: 6 months ]Hospital mortality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469882
|Contact: JOSE R AZEVEDO, MD, PhD||+55 98 firstname.lastname@example.org|
|Contact: HUGO C LIMA, MD||+55 email@example.com|
|Icu Hospital Sao Domingos||Recruiting|
|Sao Luis, Maranhão, Brazil, 65060-645|
|Contact: JOSE RAIMUNDO ARAUJO DE A AZEVEDO, MD, PhD 9832275735 firstname.lastname@example.org|
|Study Director:||WIDLANI s MONTENEGRO, RN, Ms||Hospital Sao Domingos|