Cancer, Critically Ill, Surgery
Conditions
Keywords
Cancer, ICU, Surgery, Protein, Physical Activity
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.
Interventions
DIETARY_SUPPLEMENTIntervention
Enteral feeding that will give the patient the amount of protein between 2.0 - 2.5 Kg/body weight/Day
DIETARY_SUPPLEMENTControl
Enteral feeding that will give the patient the amount of protein between 1.0 - 1.2 Kg/body weight/Day
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Function | 8 days after randomization | 6 minutes walk test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 6 months after randomization | Measurement of quality of life using the Euro-Qol 5D-5L index. EQ-5D-5L index includes five questions concerning mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A summary utility index value can be computed from subject's response to these five questions. Values range from -0.594 (worst possible health score) to 0 (death) to 1.000 (best health). |
| Body Composition related to prognosis | 8 days after randomization | Phase Angle (BIA) |
| Physical Function | 30 days after randomization | 6-minute walk test after 30 days the date of randomization; |
| Resting Energy Expenditure | one day before surgery and one day after surgery | Indirect Calorimetry |
| Length of hospital stay. | 30 days after randomization | Starts in the first day of hospitalization and ends on the day of hospital discharge |
| Postoperative complications | 30 days after randomization | Clavien Dindo |
Countries
Brazil
Contacts
Primary ContactJuliano P Almeida, Professor
Backup ContactIlana Roitman, RD
Outcome results
None listed