Fluid Therapy and Cerebral Injury in Pediatric Diabetic Ketoacidosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,389
- 试验地点
- 13
- 主要终点
- the Number of Participants With Glasgow Coma Score (GCS) < 14 Within the First 24 Hours of Treatment for Diabetic Ketoacidosis (DKA)
研究概览
简要总结
The investigators will conduct a randomized controlled trial comparing four different intravenous (IV) fluid treatment protocols for pediatric diabetic ketoacidosis (DKA). Two rates of rehydration will be compared; a more rapid rate and a slower rate. Within each of these two basic rehydration protocols, the investigators will vary the type of rehydration fluid used (0.9% saline or 0.45% saline). The investigators will compare the different treatments by conducting assessments of neurological injury, by measuring the frequency of significant cerebral edema, and by measuring long-term neurocognitive function.
These studies will allow us to determine whether variations in IV fluid treatment protocols affect acute neurological outcomes of DKA. Additionally, they will provide important data regarding the impact of DKA and DKA treatment on long-term neurocognitive function in children. In this way, the investigators hope to identify a more ideal fluid management strategy for children with DKA.
Previous studies have suggested that DKA may cause blood flow to the brain to be reduced and that brain injury might result from this reduction in blood flow and/or the effects of re-establishment of normal blood flow during DKA treatment with insulin and iv fluids. The investigators hypothesize that more rapidly re-establishing normal blood flow to the brain during DKA, by giving fluids more rapidly and using fluids with a higher sodium (salt) content, will help to minimize brain injury caused by DKA.
详细描述
These data will be compared to observational data from children with type 1 diabetes without DKA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must present or be transferred to a participating emergency department
- •age less than 18 years
- •diagnosis of DKA
- •serum glucose or fingerstick glucose concentration >300 mg/dL
- •venous pH < 7.25 OR serum bicarbonate concentration < 15 mmol/L.
排除标准
- •patients with underlying neurological disorders or neurocognitive deficits which would affect either mental status testing during treatment or subsequent neurocognitive testing after recovery
- •patients who present with concomitant alcohol or drug use, head trauma, meningitis or other conditions which might affect neurological function
- •patients transferred to one of the participating emergency departments after initiation of DKA treatment other than one 10cc/kg intravenous bolus of 0.9% saline
- •patients who are known to be pregnant at time of ED evaluation
- •patients who have been enrolled in this study twice previously
- •patients for whom the treating physician believed a specific fluid and electrolyte regimen was warranted
- •patients for whom informed consent could not be obtained within 1 hour after completion of the initial fluid bolus, or within 2 hours from initiation of fluids, whichever is longer
- •Patients who have been receiving IV fluids at a maintenance rate or greater (defined by the 4-2-1 rule) for more than two hours; OR
- •Patients for whom it has been more than four hours since DKA therapy (IV fluids, IV bolus, or IV insulin) began; OR
- •Patients who have been given hyperosmolar therapy (i.e. mannitol or 3% normal saline) prior to or since arriving at one of the participating PECARN emergency departments; OR
- •Patients for whom the treating physician intends to immediately administer hyperosmolar therapy (i.e. mannitol or 3% normal saline); OR
- •Patients whose baseline GCS is 11 or less.
研究组 & 干预措施
Rapid rehydration using 0.45% saline replacement fluid
This arm will involve more rapid intravenous fluid treatment which will include a second 10cc/Kg bolus of 0.9% saline and assume a 10% fluid deficit. 0.45% saline will be used as the replacement fluid for this arm.
干预措施: 0.45% saline replacement fluid (Drug)
Rapid rehydration using 0.9% saline replacement fluid
This arm will involve more rapid intravenous fluid treatment which will include a second 10cc/Kg bolus of 0.9% saline and assume a 10% fluid deficit. 0.9% saline will be used as the replacement fluid.
干预措施: 0.9% saline replacement fluid (Drug)
Slower rehydration using 0.45% saline intravenous fluid
This arm will involve slower rehydration (assumed 5% fluid deficit and no additional fluid bolus) with 0.45% saline used as the replacement fluid.
干预措施: 0.45% saline intravenous fluid (Drug)
Slower rehydration using 0.9% saline intravenous fluid
This arm will involve slower rehydration (assumed 5% fluid deficit and no additional fuid bolus) with 0.9% saline used as the replacement fluid.
干预措施: 0.9% saline Intravenous fluid (Drug)
结局指标
主要结局
the Number of Participants With Glasgow Coma Score (GCS) < 14 Within the First 24 Hours of Treatment for Diabetic Ketoacidosis (DKA)
时间窗: 24 hours
The primary outcome is the binary indicator that a patient's GCS score drops below 14 (i.e. abnormal score) within the first 24 hours of treatment of DKA. There will be two treatment factors: sodium concentration of re-hydration fluids and rate of rehydration. These effects will be tested separately, using the Mantel-Haenszel chi-square test, stratified by hospital, and by the other main factor.
次要结局
- Intelligence Quotient (IQ) Testing(3 months)
- Frequency of Clinically Apparent Brain Injury(24 hours)
- Hourly Improvement in Forward and Backward Digit Span Scores During DKA Treatment (Mean Difference Per Hour)(24 hours)
- Mean Scores on Tests of Memory Capacity 3 Months After Recovery From DKA.(3 months)