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Completed

NCT Number: NCT03469882

High Protein Intake and Early Exercise in Adult Intensive Care Patients

This study analyse the impact of high protein intake associated to early programed exercise on functional outcomes of adult intensive care patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icu Hospital Sao Domingos

São Luís, Maranhão, 65060-645, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High protein nutrition

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

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

Other

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

Other names: No intervention

Primary outcomes

  1. Physical component summary (PCS) 3 months after randomization

    Time frame: 3 months after randomization

    Blind assessment of PCS after 3 months after randomization

  2. Physical component summary (PCS) 6 months after randomization

    Time frame: 6 months after randomization

    Blind assessment of PCS after 6 months after randomization

Secondary outcomes

  1. handgrip strength

    Time frame: 20 days

    handgrip strength measured at ICU discharge,

  2. Duration of mechanical ventilation

    Time frame: 20 days

    Length of time under mechanical ventilation

  3. Length of ICU stay

    Time frame: 20 days

    Length of ICU stay

  4. Hospital mortality

    Time frame: 6 months

    Hospital mortality

Sponsors and collaborators

Lead sponsor

Hospital Sao Domingos

Other

Registry information

Official study title

High Protein Intake and Early Exercise in Adult Intensive Care Patients: Impact on Functional Outcomes. A Randomized Controlled Phase II Trial.

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Mar 19, 2018
Registry last updated
Jul 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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