High Protein Intake and Early Exercise in Adult Intensive Care Patients

NCT ID: NCT03469882

Last Updated: 2021-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2020-07-31

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.

Conditions

Critically Ill Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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 2.2 g/kg/day of protein and in-bed cycle ergometry exercise.

Group Type: EXPERIMENTAL

High protein nutrition

Intervention Type: DIETARY_SUPPLEMENT

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.

Cycle ergometry exercise

Intervention Type: DEVICE

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

Group Type: OTHER

Usual care group

Intervention Type: OTHER

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

Interventions

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 2.2 grams/kg/day of protein.

Intervention Type: DIETARY_SUPPLEMENT

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).

Intervention Type: DEVICE

Usual care group

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

Intervention Type: OTHER

Other Intervention Names

No intervention

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Sao Domingos

OTHER

Sponsor Role: lead

Responsible Party

José Raimundo Araujo de Azevedo

MD; PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

WIDLANI s MONTENEGRO, RN, Ms

Role: STUDY_DIRECTOR

Hospital Sao Domingos

Locations

Icu Hospital Sao Domingos

São Luís, Maranhão, Brazil

Countries

Brazil

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Other Identifiers

ICUHSD 03/18

Identifier Type: -

Identifier Source: org_study_id