Comparison of a Low Dose to a Standard Dose of Insulin in Adult Diabetic Ketoacidosis in ICU to Reduce Metabolic Complications : a Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Metabolic complications
研究概览
简要总结
Diabetic ketoacidosis (DKA), a frequent complication of diabetes, is the consequence of a profound insulin deficiency responsible for osmotic polyuria and thus major losses of water, glucose, sodium and potassium as well as a metabolic acidosis due to the uncontrolled production of ketonic acids. Management includes fluid replacement, insulin therapy and correction of metabolic disorders (including potassium loss).
Initially described in patients with type 1 diabetes (T1D), it is now often observed in patients with type 2 diabetes (T2D) in whom it is more a matter of insulin resistance than an absolute deficiency. However, international guidelines recommend a similar dose of intravenous insulin (0.10 IU/kg/hour) regardless of the type of diabetes.
During treatment, metabolic complications are frequent and potentially serious, especially in T2D due to cardiovascular comorbidities.
The research hypothesis is that decreasing the insulin dose will reduce metabolic complications without influencing time to resolution in adult patients, regardless of diabetes type.
详细描述
Diabetic ketoacidosis (DKA), a frequent complication of diabetes, is the consequence of a profound insulin deficiency responsible for osmotic polyuria which leads to major losses of water, sodium and potassium as well as the generation of metabolic acidosis due to the uncontrolled production of ketonic acids. Management includes fluid replacement, insulin therapy and correction of metabolic disorders (including potassium loss and acidosis).
Initially described in patients with type 1 diabetes (T1D), it is now often observed in patients with type 2 diabetes (T2D) in whom it is more insulin resistance than absolute deficiency. However, international guidelines recommend a similar dosage of intravenous insulin (0.10 IU/kg/hour) regardless of the type of diabetes.
During treatment, metabolic complications are frequent and potentially serious, especially in T2D due to cardiovascular comorbidities.
A British study reported 27.6% hypoglycaemia and 55% hypokalemia during the first 24 hours of treatment. Comparable figures were observed by conducting a multicenter retrospective study of 122 patients: hypokalaemia and hypoglycaemia were observed in nearly two thirds of cases.
A pediatric study showed that a lower dose of insulin (0.05 IU/kg/h) reduced the rate of hypoglycaemia (20% vs 4%) and hypokalaemia (48% vs 20%) compared to at the standard dose (0.10 IU/kg/h) without modifying the time to resolution. But the very small number (25 children per arm), the questionable statistical analysis and the pediatric population (T1D only) do not make it possible to anticipate the potential benefit in a much more heterogeneous adult population.
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, Investigator)
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
- •Patient aged 18 years or above
- •Admission in Intense/Intermediate Care Unit
- •Severe DKA due to all types of diabetes (T1D, T2D and secondary diabetes and inaugural ketoacidosis) defined by association of the following 3 parameters:
- •glucose > 11 mmol/L or affirmation of having diabetes
- •ketonemia > 3mmol/L or ketonuria ≥ 2
- •bicarbonate < 15 mmol/L and/or venous pH < or=7.3
- •Randomization possible before 15UI of insulin administrated in total
- •Informed and written consent. In the absence of parent/ relative/ person of trust, the patient may be included via the emergency procedure and consent will be obtained as soon as possible
排除标准
- •Non-diabetic ketoacidosis (fasting or alcoholic)
- •Patient weighing less than 30 kg
- •Hypokalemia < 3.5 mmol/L at the time of inclusion
- •Hyperosmolar hyperglycemic state (defined as efficient plasma osmolarity > 320 mosmol/L)
- •Absence of social security coverage
- •Pregnant or breastfeeding patient
- •Patient under tutelage or curators
- •Patient deprived of liberty due to a judicial or administrative decision
- •Patient with a renal disease requiring dialysis
- •Acute or chronic liver failure with Factor V < 50%
- •Patient receiving a high dose of corticosteroids (≥ 0.5 mg/kg) daily
- •Patient included in another interventional study
研究组 & 干预措施
Experimental
Reduced dose of rapid-acting insulin of 0.05 IU/kg/h from randomization until resolution of DKA
干预措施: Insulin 0.05 IU/kg/h (Drug)
Control
Rapid-acting insulin dose of 0.10 IU/kg/h in accordance with usual recommendations until resolution of DKA
干预措施: Insulin 0.10 IU/kg/h (Drug)
结局指标
主要结局
Metabolic complications
时间窗: 48 hours
Proportion of patients with metabolic complications (hypokalaemia \<3.5 mmol/L and/or hypoglycemia \<3.9 mmol/L) treated with a reduced dose of insulin (0.05 IU/kg/h) compared with the control group receiving the 0.10 IU/kg/h dose.
次要结局
- Cardiac arrythmia diagnosed by EKG(48 hours)
- Resolution of diabetic ketoacidosis(48 hours)
- Episode of hypoglycemia(48 hours)
- Episode of severe hypoglycemia(48 hours)
- Glucose infusion 1000mL(48 hours)
- Time between patient randomization and resolution of DKA in T2D population(48 hours)
- Episode of hypokalaemia(48 hours)
- Time between patient randomization and resolution of DKA in patients suffering from first ketoacidosis episode(48 hours)
- Episode of hypokalaemia in T1D population(48 hours)
- Episode of hypokalaemia in T2D population(48 hours)
- Episode of hypokalaemia in patients suffering from first ketoacidosis episode(48 hours)
- Episode of hypoglycaemia in T2D population(48 hours)
- Glucose infusion of 30% glucose solution(48 hours)
- Amount of glucose perfused(48 hours)
- Potassium intake(48 hours)
- Length of stay in ICU(48 hours)
- Time between patient randomization and resolution of DKA in T1D population(48 hours)
- Episode of hypoglycaemia in T1D population(48 hours)
- Episode of hypoglycaemia in patients suffering from first ketoacidosis episode(48 hours)
- Episode of severe hypoglycaemia in T1D population(48 hours)
- Episode of severe hypoglycaemia in T2D population(48 hours)
- Episode of severe hypoglycaemia in patients suffering from first ketoacidosis episode(48 hours)