Starvation in the Treatment of Diabetic Ketoacidosis: Is There Enough Evidence to Support This Practice?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Resolution of DKA
研究概览
简要总结
Diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS) are common, but serious metabolic disorders are often encountered in intensive care. In the intensive care setting, it is common to withhold food from patients during treatment of DKA. However, there is no evidence or current literature supporting this practice. The following proposed research investigates the initiation of an early diet versus withholding food during the treatment of diabetic ketoacidosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females with the diagnosis of diabetic ketoacidosis (defined as blood glucose greater than 250 mg/dL, arterial pH less than 7.3, serum bicarbonate less than 15 mEq/L, and the presence of ketonemia or ketonuria)
- •Age between 18-89
- •Admission to the Medical Intensive Care Unit
- •Able to provide informed consent
排除标准
- •Pregnant and breast-feeding women
- •Institutionalized patients or prisoners
- •Patients unable to eat by mouth, including intubation, presence of any tube used for enteral feeding (nasogastric tube, orogastric tube, PEG tube, etc.), medical conditions requiring parenteral feeding, and a history of a medical condition that prevented oral intake prior to admission, including achalasia, esophageal cancer, stroke with residual deficits preventing oral intake, amyotrophic lateral sclerosis, or head and neck trauma.
研究组 & 干预措施
Early feeding
If randomized to the experimental group, patient's diet will be advanced to clear liquid for the first day. On the second day, diet will be advanced to full liquid and advanced up to oral (carb controlled 1600 calories) diet as tolerated.
干预措施: Early feeding with an oral diet (Other)
Nothing per mouth
Patient will be kept without PO intake until they are bridged from the insulin drip
结局指标
主要结局
Resolution of DKA
时间窗: Typically resolution of DKA is 24-72 hours, may be up to 5 days in some patients
Defined as a closed anion gap. Adjusted Anion Gap defined as (Blood Sodium - Blood Chloride - Blood Bicarbonate) + 0.25 x ((normal albumin (4.0)) x (observed albumin)); Elevated Anion Gap is \>12
Length of stay in the medical intensive care unit (in days).
时间窗: Days (Typically 3-5 days in the MICU, may be up to 1 week).
The time from admission order is placed to the time the transfer to another unit order is placed
次要结局
- Length of stay in the hospital(3-7 days, may be up to 1-2 weeks.)
- mortality(30 day)