The Efficiency of Different Amount of Protein Intake Associated With a Physical Activity Protocol in Surgical Cancer Patients Admitted to the Intensive Care Unit : Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- University of Sao Paulo
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Physical Function
- Last Updated
- 8 years ago
Overview
Brief Summary
This is a Randomized Controlled Trial . The purpose of this study is to assess the hypothesis that whether a high protein diet combined with a physical activity protocol in surgical cancer patients admitted to the ICU in the post operative period is associated with better physical function at the hospital discharge as well as a better quality of life.
Detailed Description
Surgical cancer patients will be categorized by their nutritional risk using a specific screening toll. During the hospital stay some measurements will be done. Such as resting energy expenditure (REE) before and after surgery; physical function evaluation; strength and quality of life. The proposed intervention is a post operative diet with a different amount of protein (diet with a standard amount of protein and a diet with high amount of protein) associated to an institutional protocol of physical activity.
Investigators
Juliano P Almeida, MD, PhD
Medical Doctor
University of Sao Paulo
Eligibility Criteria
Inclusion Criteria
- •Cancer patients
- •Age greater than or equal to 18 years old
- •Have a tendency to be admitted to the ICU after the surgery
- •Fill the eligible criteria to start enteral feeding within 72 hours
- •Sign the consent form;
Exclusion Criteria
- •Mechanical ventilation such as fraction of inspired oxygen inspired oxygen fraction (FiO2) \>60% or positive end expiratory pressure (PEEP) \> 12cm H2O
- •Bronchopleural fistula
- •Karnofsky \<50
- •Participant cannot b enrolled in another study
Outcomes
Primary Outcomes
Physical Function
Time Frame: 8 days after randomization
6 minutes walk test
Secondary Outcomes
- Postoperative complications(30 days after randomization)
- Physical Function(30 days after randomization)
- Quality of life(6 months after randomization)
- Body Composition related to prognosis(8 days after randomization)
- Resting Energy Expenditure(one day before surgery and one day after surgery)
- Length of hospital stay.(30 days after randomization)