Clinical Trial: Refeeding Syndrome in Cancer Patients

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Refeeding Syndrome in Cancer Patients Admitted to Adult Intensive Care Unit

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 Summary: 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.
Sponsor: University of Sao Paulo

Current Primary Outcome: Logistic Organ Dysfunction Score [ Time Frame: 72 hours ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • ICU length of stay [ Time Frame: 30 days ]
    Number of days in the ICU
  • Hospital length of stay [ Time Frame: 30 days ]
    Number of days in hospital
  • Days in mechanical ventilation [ Time Frame: 30 days ]
    Number of days in mechanical ventilation
  • Days in vasopressor therapy [ Time Frame: 30 days ]
    Number of days using vasopressor therapy
  • Cardiovascular events [ Time Frame: 30 days ]
    Incidence of acute ischemic event or acute heart failure
  • Delirium [ Time Frame: 30 days ]
    Incidence of delirium according to CAM-ICU
  • Acute kidney injury [ Time Frame: 30 days ]
    Incidence of acute kidney injury according to KDIGO
  • Mortality [ Time Frame: 30 days ]
    Incidence of all-cause mortality
  • Renal Replacement Therapy [ Time Frame: 30 days ]
    Number of days in renal replacement therapy
  • Acute ischemic stroke [ Time Frame: 30 days ]
    Incidence of acute ischemic stroke
  • Seizures [ Time Frame: 30 days ]
    Number of seizure episodes
  • Adverse events [ Time Frame: 30 days ]
    Number of episodes of the following events: hypoglycemia, diarrhea, ileous, nausea and vomiting.


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: August 23, 2015
Date Started: July 2015
Date Completion: February 2017
Last Updated: August 24, 2015
Last Verified: August 2015