High Protein Intake and Early Exercise in Adult Intensive Care Patients

Not Applicable

Completed

• Conditions: Critically Ill Patients
• Interventions: Other: Usual care group; Dietary Supplement: High protein nutrition; Device: Cycle ergometry exercise

• Registration Number: NCT03469882
• Lead Sponsor: Hospital Sao Domingos

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.

Study Timeline

• Study First Submitted: 2018-03-11
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-19
• Study Start: 2018-06-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-07-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-24
• Last Update Posted: 2021-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High protein and exercise (HPE) group	Cycle ergometry exercise	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.
Usual care group	Usual care group	Participants randomized to the usual care group will receive usual care protein and exercise
High protein and exercise (HPE) group	High protein nutrition	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.

Primary Outcome Measures

Name	Time	Method
Physical component summary (PCS) 3 months after randomization	3 months after randomization	Blind assessment of PCS after 3 months after randomization
Physical component summary (PCS) 6 months after randomization	6 months after randomization	Blind assessment of PCS after 6 months after randomization

Secondary Outcome Measures

Name	Time	Method
handgrip strength	20 days	handgrip strength measured at ICU discharge,
Duration of mechanical ventilation	20 days	Length of time under mechanical ventilation
Length of ICU stay	20 days	Length of ICU stay
Hospital mortality	6 months	Hospital mortality

Trial Locations

Locations (1)

Icu Hospital Sao Domingos; 🇧🇷 Sao Luis, Maranhão, Brazil