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Trial record 8 of 13 for:    24108501 [PUBMED-IDS]

High Protein Intake and Early Exercise in Adult Intensive Care Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03469882
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : May 6, 2019
Information provided by (Responsible Party):
José Raimundo Araujo de Azevedo, 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.

Condition or disease Intervention/treatment Phase
Critically Ill Patients Dietary Supplement: High protein nutrition Device: Cycle ergometry exercise Other: Usual care group Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized controlled phase 2 study
Masking: Single (Outcomes Assessor)
Masking Description: Blinded outcomes assessment
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

We will include 120 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03469882

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Contact: JOSE R AZEVEDO, MD, PhD +55 98 32168110
Contact: HUGO C LIMA, MD +55 9832168110

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Icu Hospital Sao Domingos Recruiting
Sao Luis, Maranhão, Brazil, 65060-645
Contact: JOSE RAIMUNDO ARAUJO DE A AZEVEDO, MD, PhD    9832275735   
Sponsors and Collaborators
Hospital Sao Domingos
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Study Director: WIDLANI s MONTENEGRO, RN, Ms Hospital Sao Domingos

Ciconelli RM, Ferraz MB, Santos W, Meirão 1, Quaresma MR. Brazilian-portuguese version of the SF-36. A reliable and valid quality of life outcome measure. Rev Bras Reumatologia. 1999; 39 (3): 143-50.

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Responsible Party: José Raimundo Araujo de Azevedo, MD; PhD, Hospital Sao Domingos Identifier: NCT03469882     History of Changes
Other Study ID Numbers: ICUHSD 03/18
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by José Raimundo Araujo de Azevedo, Hospital Sao Domingos:
Protein, exercise, critical illness, outcome,
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes