Refeeding Syndrome in Cancer Patients (RESCUE)

University of Sao Paulo

Status and phase: Withdrawn; Phase 2

Conditions: Refeeding Syndrome; Critical Illness; Cancer

Treatments: Drug: Caloric Management Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT02534181

1.015.415

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Intervention group

Active Comparator group

Description:

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.

Treatment:

Drug: Caloric Management Protocol

Control group

No Intervention group

Description:

1. Nutritional management will be followed according to institutional protocol. 2. Electrolyte replacement will be provided at the clinician's discretion.