Cancer, Critical Illness, Refeeding Syndrome
Conditions
Keywords
Refeeding Syndrome, Cancer
Brief summary
The purpose of this study is to evaluate whether a nutritional strategy is effective in critically ill patients with cancer diagnosed with refeeding syndrome.
Detailed description
Refeeding syndrome is a clinical entity triggered by the introduction of calories in chronically undernourished patients. A number of organs may be affected due to imbalance of fluids and electrolytes. In the intensive care setting, there are no formal guidelines to recommend the appropriate treatment of this condition. The aim of this study is to evaluate the implementation of a nutritional protocol to address cancer patients admitted to the ICU with refeeding syndrome.
Interventions
DRUGCaloric Management Protocol
Strategy based on reduction of nutritional intake and electrolyte replacement.
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
* Initiation of any type of nutrition (enteral, parenteral or glucose solution of at least 10% concentration) in the ICU in the last 48 hours; * Reduction of serum phosphorus to a level below 2.5mg/dL with a drop above 0.5mg/dL compared to a previous measurement; * Caloric intake greater than 500kcal in the last 24 hours; * Central venous access for electrolyte replacement; * Signature of the informed consent form.
Exclusion criteria
* Use of enteral or parenteral nutrition before ICU admission; * Prediction of ICU discharge in the following 2 days; * End-stage renal disease; * Admission for diabetic ketoacidosis or hyperosmolar hyperglycemic state; * Recent treatment of hyperphosphatemia; * Parathyroidectomy surgery; * Participation in another study; * Refusal to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Logistic Organ Dysfunction Score | 72 hours | Score of the number and severity of organ failures during ICU stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital length of stay | 30 days | Number of days in hospital |
| Days in mechanical ventilation | 30 days | Number of days in mechanical ventilation |
| Days in vasopressor therapy | 30 days | Number of days using vasopressor therapy |
| Cardiovascular events | 30 days | Incidence of acute ischemic event or acute heart failure |
| Delirium | 30 days | Incidence of delirium according to CAM-ICU |
| ICU length of stay | 30 days | Number of days in the ICU |
| Mortality | 30 days | Incidence of all-cause mortality |
| Renal Replacement Therapy | 30 days | Number of days in renal replacement therapy |
| Acute ischemic stroke | 30 days | Incidence of acute ischemic stroke |
| Seizures | 30 days | Number of seizure episodes |
| Adverse events | 30 days | Number of episodes of the following events: hypoglycemia, diarrhea, ileous, nausea and vomiting. |
| Acute kidney injury | 30 days | Incidence of acute kidney injury according to KDIGO |
Outcome results
None listed