Refeeding Syndrome in Cancer Patients

University of Sao Paulo

Overview

The purpose of this study is to evaluate whether a nutritional strategy is effective in critically ill patients with cancer diagnosed with refeeding syndrome.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Refeeding Syndrome Cancer Critical Illness

Interventions

Caloric Management ProtocolDRUG

Strategy based on reduction of nutritional intake and electrolyte replacement.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Logistic Organ Dysfunction Score

Score of the number and severity of organ failures during ICU stay

Time frame: 72 hours

Secondary Outcomes

ICU length of stay

Number of days in the ICU

Time frame: 30 days

Hospital length of stay

Number of days in hospital

Time frame: 30 days

Days in mechanical ventilation

Number of days in mechanical ventilation

Time frame: 30 days

Days in vasopressor therapy

Number of days using vasopressor therapy

Time frame: 30 days

Cardiovascular events

Incidence of acute ischemic event or acute heart failure

Time frame: 30 days

Delirium

Incidence of delirium according to CAM-ICU

Time frame: 30 days

Acute kidney injury

Incidence of acute kidney injury according to KDIGO

Time frame: 30 days

Mortality

Incidence of all-cause mortality

Time frame: 30 days

Renal Replacement Therapy

Data from ClinicalTrials.gov

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