Refeeding Syndrome in Cancer Patients Admitted to Adult Intensive Care Unit
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Logistic Organ Dysfunction Score
研究概览
简要总结
The purpose of this study is to evaluate whether a nutritional strategy is effective in critically ill patients with cancer diagnosed with refeeding syndrome.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention group
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.
干预措施: Caloric Management Protocol (Drug)
结局指标
主要结局
Logistic Organ Dysfunction Score
时间窗: 72 hours
Score of the number and severity of organ failures during ICU stay
次要结局
- ICU length of stay(30 days)
- Acute ischemic stroke(30 days)
- Seizures(30 days)
- Adverse events(30 days)
- Hospital length of stay(30 days)
- Days in mechanical ventilation(30 days)
- Days in vasopressor therapy(30 days)
- Cardiovascular events(30 days)
- Delirium(30 days)
- Acute kidney injury(30 days)
- Mortality(30 days)
- Renal Replacement Therapy(30 days)
研究者
Eduardo Atsushi Osawa
ICU Consultant Physician
University of Sao Paulo