The "Two Bag" System for Treatment of Adults With Diabetic Ketoacidosis: a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Time to Anion Gap Closure in Hours
研究概览
简要总结
This is a study investigating the best way to treat diabetic ketoacidosis (DKA) with intravenous (IV) fluids in the hospital. The purpose of this study is to determine whether the "two bag" system of administering IV fluids for the treatment of adults with DKA leads to a shorter time requiring intravenous insulin (a shorter time to anion gap closure), when compared to usual care the traditional "one bag" system of IV fluids. Participants will be assigned randomly to either the usual care group or the "two bag" system group. Based on studies performed in the past, the investigators predict that patients treated with the two bag system of IV fluids for DKA will have a significantly shorter time requiring treatment with intravenous insulin when compared to the traditional one bag system.
详细描述
The two bag system has been studied in the pediatric population and is used frequently in pediatric intensive care units. It involves two bags of identical fluids with electrolytes, except one bag has 0% dextrose and the other has 10% dextrose. The two fluid bags run simultaneously into a single IV. The rates of the two fluid bags are adjusted according to the patient's blood sugar. Since the hyperglycemia in DKA typically corrects before the ketosis, this provides a more efficient method of titrating the dextrose concentration based on the patient's needs, while continuing to infuse the insulin at a constant rate to prevent further ketogenesis. The benefits of the two bag system from the pediatric literature include: decreased response time to IV fluid changes, decreased time to correction of bicarbonate and ketones, and decreased total IV fluid volume administered. There was one retrospective study of the two bag system in adults, which showed decreased time to anion gap closure and decreased hypoglycemic events. To this date, there are no prospective randomized trials to evaluate the efficacy of the two bag system in adults.
Patients admitted with DKA in the critical care pavilion will be randomized to either the "two bag system" or "usual care" group.
Patients in both groups will be treated for DKA with IV fluid resuscitation for dehydration and an insulin infusion according to usual care, recommended at 0.1 U/kg/hr.
The two bag system of IV fluids will be ordered as delineated below:
If blood sugar is > 300, run D10 solution at 0 ml/hr and saline solution at 200 ml/hr.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diabetic ketoacidosis defined as:
- •Blood sugar greater than 250 mg/dl
- •Venous pH less than 7.25
- •Bicarbonate less than 18
- •Evidence of ketone formation with either positive urine ketones or elevated beta-hydroxybutyrate > 3
- •Anion gap greater than 10 +/ - 2 (or higher than expected anion gap corrected for albumin)
- •18-85 years of age
排除标准
- •Hyperglycemic hyperosmolar state
- •Ketosis from other etiology such as starvation or alcoholic ketosis
- •Acute exacerbation of congestive heart failure
- •Acute coronary syndrome or non-ST elevation MI
- •Pulmonary edema from other cause such as decompensated liver failure or acute renal failure
- •Renal failure requiring renal replacement therapy (hemodialysis)
- •Septic shock
结局指标
主要结局
Time to Anion Gap Closure in Hours
时间窗: while in DKA
Anion gap (Na - Cl - HCO3) is within normal range when corrected for the albumin (time to anion gap closure will be defined as the time to the first occurrence of a normal anion gap).
次要结局
- Number of Participants Experiencing Hypoglycemic Episodes(while in DKA)
- Number of Participants Experiencing Hypoxic Episodes(while in DKA)
- Chest Pain With EKG Changes(while in DKA)
- Pulmonary Edema(while in DKA)
- Hyponatremia Events(while in DKA)
- Hypokalemia Events(while in DKA)
- ICU Length of Stay(during hospitalization)
- Changes in Mental Status(while in DKA)
- Total Volume of Intravenous Fluids Administered(while in DKA)
- Hypernatremia(while in DKA)
- Hyperkalemia(while in DKA)
研究者
Vidya Krishnan
Professor, Case Western Reserve University
MetroHealth Medical Center