Refeeding Syndrome in Cancer Patients

Phase 2

Withdrawn

• Conditions: Cancer; Refeeding Syndrome; Critical Illness
• Interventions: Drug: Caloric Management Protocol

• Registration Number: NCT02534181
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-23
• Study First Submitted QC: 2015-08-24
• Study First Posted: 2015-08-27
• Primary Completion: 2016-12
• Study Completion: 2017-02
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Caloric Management Protocol	Patients will undergo a caloric management protocol: Days 1 and 2: 1. Reduction of caloric intake to 5kcal/kg/day; 2. Replacement of serum phosforus, potassium and magnesium; 3. Administration of 100mg intravenous thiamine, vitamins and microelements. From day 3: 1. If serum phosphorus \< 2.5mg/dL, protocol will be followed according to day 2; 2. If serum phosphorus \> 2.5mg/dL, a gradual increase to target caloric intake will ensue.

Primary Outcome Measures

Name	Time	Method
Logistic Organ Dysfunction Score	72 hours	Score of the number and severity of organ failures during ICU stay

Secondary Outcome Measures

Name	Time	Method
Renal Replacement Therapy	30 days	Number of days in renal replacement therapy
ICU length of stay	30 days	Number of days in the ICU
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.
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
Acute kidney injury	30 days	Incidence of acute kidney injury according to KDIGO
Mortality	30 days	Incidence of all-cause mortality