Refeeding Syndrome in Cancer Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer, Refeeding Syndrome, Critical Illness

Intervention / Treatment
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* Drug: Caloric Management Protocol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>Patients will undergo a caloric management protocol: Days 1 and 2: Reduction of caloric intake to 5kcal/kg/day; Replacement of serum phosforus, potassium and magnesium; Administration of 100mg intravenous thiamine, vitamins and microelements. From day 3: If serum phosphorus < 2.5mg/dL, protocol will be followed according to day 2; If serum phosphorus > 2.5mg/dL, a gradual increase to target caloric intake will ensue. | Drug: Caloric Management Protocol<br>* Strategy based on reduction of nutritional intake and electrolyte replacement.<br>|
| No Intervention: Control group<br>Nutritional management will be followed according to institutional protocol. Electrolyte replacement will be provided at the clinician's discretion. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Logistic Organ Dysfunction Score | Score of the number and severity of organ failures during ICU stay | 72 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refeeding Syndrome, Cancer