Refeeding Syndrome in Cancer Patients

Cancer Clinical Trial

— RESCUE  

Official title:

Refeeding Syndrome in Cancer Patients Admitted to Adult Intensive Care Unit

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02534181
• Other study ID #: 1.015.415
• Status: Withdrawn
• Phase: Phase 2
• First received: August 23, 2015
• Last updated: January 8, 2018
• Start date: July 2015
• Est. completion date: February 2017

Study information

• Verified date: January 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Critical Illness
• Refeeding Syndrome
• Syndrome

Intervention

Drug:
• Caloric Management Protocol
Strategy based on reduction of nutritional intake and electrolyte replacement.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Logistic Organ Dysfunction Score	Score of the number and severity of organ failures during ICU stay	72 hours
Secondary	ICU length of stay	Number of days in the ICU	30 days
Secondary	Hospital length of stay	Number of days in hospital	30 days
Secondary	Days in mechanical ventilation	Number of days in mechanical ventilation	30 days
Secondary	Days in vasopressor therapy	Number of days using vasopressor therapy	30 days
Secondary	Cardiovascular events	Incidence of acute ischemic event or acute heart failure	30 days
Secondary	Delirium	Incidence of delirium according to CAM-ICU	30 days
Secondary	Acute kidney injury	Incidence of acute kidney injury according to KDIGO	30 days
Secondary	Mortality	Incidence of all-cause mortality	30 days
Secondary	Renal Replacement Therapy	Number of days in renal replacement therapy	30 days
Secondary	Acute ischemic stroke	Incidence of acute ischemic stroke	30 days
Secondary	Seizures	Number of seizure episodes	30 days
Secondary	Adverse events	Number of episodes of the following events: hypoglycemia, diarrhea, ileous, nausea and vomiting.	30 days

External Links

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