Insulin Resistance Versus Absolute Insulin Deficiency: Evaluating the Mechanism of Hyperglycemia in Pediatric Critical Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 1
- 主要终点
- We hypothesize that the hyperglycemic response to critical illness will be associated with abnormally low levels of endogenous insulin as compared to patients without critical illness hyperglycemia.
研究概览
简要总结
BACKGROUND AND PURPOSE
Critical illness hyperglycemia (CIH) - elevated blood glucose in the critically ill patient population - has gained much interest among health care providers over the past several years. Clinical studies in adults have documented a high rate of hyperglycemia in some post-surgical and medical intensive care units (ICUs). However, the primary reasons for interest in this topic are not due just to its high rate, but also to the fact that by returning the high glucose levels found in this population to normal with insulin therapy can dramatically improve clinical outcomes by decreasing both morbidity and long-term mortality. Because of this, aggressive glucose control has become common practice in adult ICU critical care management.
Although there is substantial data describing the high incidence of CIH in adult patients, there is little information regarding this condition in children. A single retrospective study recently published also suggested a high incidence of CIH in children with critical illness secondary to both medical and surgical causes. It is yet to be determined if, like in adults, normalizing blood glucose levels with insulin improves outcomes in this pediatric population. Because evidence appears compelling that hyperglycemia is both common and detrimental in adults, many pediatric ICUs have likewise begun to focus on aggressively treating hyperglycemia in critically ill children.
The proposed study is a prospective observational pilot study to occur in the Pediatric Intensive Care Unit (PICU) at Children's Healthcare of Atlanta at Egleston. This prospective pilot study is being done to evaluate the endocrine factors associated with, if not responsible for, CIH, and the changes that take place with the restoration of normal blood glucose levels by insulin therapy.
To address these profound issues this study will pursue two interrelated Aims:
Aim #1: To determine if critical illness hyperglycemia is associated with absolute insulin deficiency, peripheral insulin resistance, or both.
Aim #2: To characterize the requirement of insulin required to initially restore and maintain normal blood glucose levels, and compare the changes in insulin that take place with this normalization in patients with CIH.
We hypothesize that the hyperglycemic response to critical illness will be associated with abnormally low levels of insulin as compared to patients without critical illness hyperglycemia.
详细描述
SUMMARY OF PROCEDURES
This will be an approximately 12 month long, single center, prospective study of patients between ages 2 and 12 years old who meet criteria for CIH in our pediatric intensive care unit during the period of enrollment. Patients will be screened by physicians and staff and evaluated via inclusion and exclusion criteria, the evaluation will discussed with the family/legal guardian by appointed critical care fellow, attending or physician appointee, and the patient will be enrolled if informed consent is granted. Following informed consent approval from family/legal guardian, blood samples will be collected and sent for storage and processing in the clinical laboratory at Children's.
Three patient population groups will be assessed in this study:
- Group A - Study Patients - At risk for CIH/with CIH Labs will be drawn in our target population at diagnosis of CIH and sent for insulin and C-peptide levels. These levels will be repeated 24 hours after initiation of insulin, and then followed every three days until insulin is no longer needed, then repeated once more 24 hours after insulin is off (see protocol).
- Group B - Control Patients - At risk for CIH/without CIH Insulin and C-peptide levels will be drawn in a control group of patients with the same risk factors but without CIH at the time of admission, 24 hours after admission, then in 3 days.
- Group C - Control Patients - Not at risk for CIH/without CIH The same protocol of lab schedules will be used in a second control group consisting of patients that are not deemed at risk for critical illness hyperglycemia.
III. POTENTIAL RISKS
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- All patients between ages 2 and 12 years of age admitted to the pediatric ICU who meet criteria for critical illness hyperglycemia (ie: all patients on mechanical ventilation, all patients on vasoactive medications, patients deemed otherwise "at risk" for CIH by attending service) and are started on our standard CIH screening and treatment protocol will comprise the pool of potential study candidates.
排除标准
- •- Certain patients who meet criteria for critical illness hyperglycemia and thus are started on insulin will be excluded from this study: Age Patients less than 2 or greater than 12 years of age will be excluded from this study to decrease age variability.
- •Pre-existing known endocrine disorder Patients with known or suspected Type 1 diabetes will be excluded because of their pre-existing absolute lack of insulin production secondary to autoimmune β cell destruction.
- •Oncology patients Oncology patients will be excluded because of the effects of immunosuppressants on study markers.
- •Renal replacement therapy Patients on continuous veno-venous hemofiltration (CVVH) or any type of dialysis (intermittent dialysis, peritoneal dialysis) will be excluded as it is unclear how different forms of renal replacement therapy affect insulin levels, and certain types of dialysis affect glucose and insulin levels (i.e. dextrose containing PD fluid).
- •Non-adherence Inability or unwillingness of the legal guardian to provide consent, or unwillingness of the child to provide assent.
结局指标
主要结局
We hypothesize that the hyperglycemic response to critical illness will be associated with abnormally low levels of endogenous insulin as compared to patients without critical illness hyperglycemia.
时间窗: At time of consent, 24 hours, 72 hours, and if applicable every additional 72 hours until insulin discontinued. A final lab 24 hours after D/C of insulin will be performed.
次要结局
未报告次要终点