Clinical trial NCT03469882: High Protein Intake and Early Exercise in Adult Intensive Care Patients
Official title: High Protein Intake and Early Exercise in Adult Intensive Care Patients: Impact on Functional Outcomes. A Randomized Controlled Phase II Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill Patients
Keywords: Protein, exercise, critical illness, outcome,
Lead sponsor: Hospital Sao Domingos
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical component summary (PCS) 3 months after randomization
timeFrame: 3 months after randomization
measure: Physical component summary (PCS) 6 months after randomization
timeFrame: 6 months after randomization
Secondary outcomes:
measure: handgrip strength
timeFrame: 20 days
measure: Duration of mechanical ventilation
timeFrame: 20 days
measure: Length of ICU stay
timeFrame: 20 days
measure: Hospital mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Sao Luis
country: Brazil
facility: Icu Hospital Sao Domingos
state: Maranhão
Study officials:
affiliation: Hospital Sao Domingos
name: WIDLANI s MONTENEGRO, RN, Ms
role: STUDY_DIRECTOR
References:
citation: Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available.
citation: Fan E, Dowdy DW, Colantuoni E, Mendez-Tellez PA, Sevransky JE, Shanholtz C, Himmelfarb CR, Desai SV, Ciesla N, Herridge MS, Pronovost PJ, Needham DM. Physical complications in acute lung injury survivors: a two-year longitudinal prospective study. Crit Care Med. 2014 Apr;42(4):849-59. doi: 10.1097/CCM.0000000000000040.
citation: Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.
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citation: National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Rice TW, Wheeler AP, Thompson BT, Steingrub J, Hite RD, Moss M, Morris A, Dong N, Rock P. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012 Feb 22;307(8):795-803. doi: 10.1001/jama.2012.137. Epub 2012 Feb 5.
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