A Single-center Randomized Double Blinded Control Trial of Intravenous Fluid Content in Children With Diabetic Ketoacidosis Admitted to the Pediatric Intensive Care Unit
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Length of Acidosis
研究概览
简要总结
Objectives: Intravenous (IV) fluid administration is a fundamental component of diabetic ketoacidosis (DKA) treatment. Normal saline (NS), the most common IV fluid used in DKA management, contains more chloride than human blood. Excessive amounts of chloride have been shown to cause a detrimental metabolic acidosis. Other IV fluids have more physiologic chloride levels, such as lactated ringers (LR). This study will compare the rates of hyperchloremic metabolic acidosis in children treated with NS to those treated with LR to determine the effect on overall length of acidosis and length of stay in the hospital or intensive care unit.
Design: Single-center, double blinded, randomized controlled trial.
Subjects: Children aged 0 to 18 years who present with diabetic ketoacidosis and require pediatric intensive care unit admission. Patients with evidence of shock, multi-organ failure or clinically significant cerebral edema will be excluded. The projected study population will be 104 patients, 52 in each arm.
Interventions: Patients will be enrolled within 1 hour of presentation to the emergency room or pediatric intensive care unit if transferred directly from another facility. They will be randomized to receive intravenous fluids containing 0.9% saline or lactated ringers. All patients will be treated using the institutional DKA protocol with the content of the intravenous fluids being the only difference in treatment between arms. Study intervention lasts until the end of the acute management of DKA.
Planned measurements and study outcomes: The primary study outcome will be duration of metabolic acidosis. Resolution of metabolic acidosis will be defined in three ways: 1. Normalization of the ketosis; 2. Normalization of the serum pH; 3. Normalization of the serum bicarbonate level. Secondary outcomes will include length of stay in the pediatric intensive care unit and length of stay in the hospital. All outcomes will be correlated with the overall chloride load given via intravenous fluids during DKA management. Regression modelling will control for any baseline differences between the groups in regards to severity of DKA, and if newly diagnosed or poorly controlled diabetes mellitus.
详细描述
There have been limited prospective clinical studies in pediatrics patients examining the association of the chloride content of intravenous fluids and outcome in DKA. This prospective randomized controlled trial is being performed to compare the duration of acidosis and hospital length of stay in children with DKA who are admitted to a pediatric intensive care unit and are treated with intravenous fluids containing NS or LR. The primary study hypothesis is that use of LR will be associated with decreased duration of hyperchloremic metabolic acidosis and, therefore, shorter hospitalization than use of NS in the treatment of pediatric DKA.
Primary hypothesis: Children with diabetic ketoacidosis (DKA) who are treated with intravenous fluids containing lactated ringers (LR) will have a shorter duration of hyperchloremic metabolic acidosis after hospital admission than those treated with intravenous fluids containing normal saline (NS).
Secondary hypothesis: The duration of acidosis after hospital admission in children with DKA will be associated with length of stay in the intensive care unit and hospital.
Outcomes
Primary outcome
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The intravenous fluids administered will all have generic labeling making the study arm assignment unknown to all providers, study personnel and participants. Only the pharmacist filling the orders will known arm assignment.
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 0 and 18 years
- •Diagnosis of DKA:
- •Venous pH less than 7.25
- •Ketonuria as confirmed on urine point-of-care testing or urinalysis
- •Hyperglycemia (Serum glucose > 200 mg/dl)
- •Serum bicarbonate <15 mmol/L
- •PICU admission
排除标准
- •Age > 18 Years
- •Physician discretion
- •Septic or hypovolemic shock
- •Signs of life-threatening cerebral edema or multi-organ failure upon presentation to the emergency room or pediatric intensive care unit
- •Enrollment time more than 1 hr since arrival to emergency room or PICU
研究组 & 干预措施
Normal Saline
Intervention: intravenous solutions containing only normal saline as the primary base during the entire treatment of diabetic ketoacidosis.
干预措施: Normal saline (Drug)
Lactated Ringers
Intervention: intravenous solutions containing only lactated ringers as the primary base during the entire treatment of diabetic ketoacidosis.
干预措施: Lactated Ringers (Drug)
结局指标
主要结局
Length of Acidosis
时间窗: 28 days
Hours to pH\>7.25 and normal anion gap and serum bicarbonate over 15
次要结局
- Length of Stay in the Pediatric Intensive Care Unit(28 days)
- Length of Stay in the Hospital(28 days)
研究者
Amanda B. Hassinger
Principal Investigator
State University of New York at Buffalo