Maintaining Normal Blood Sugar Levels in Children Undergoing Heart Surgery to Reduce the Risk of Infections and Improve Recovery (The SPECS Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 989
- 试验地点
- 2
- 主要终点
- Incidence of Nosocomial Infections in the Cardiac ICU
研究概览
简要总结
Critically ill children, including children undergoing heart surgery, commonly develop elevated blood glucose (also known as "blood sugar") levels during their illness, which can lead to poor health outcomes and an increased risk of death. This study will examine the effectiveness of maintaining normal blood glucose levels at decreasing infections and improving recovery in young children undergoing heart surgery.
详细描述
Children undergoing heart surgery are under significant bodily stress, which can lead to higher than normal or lower than normal blood glucose levels. A synthetic form of insulin, a naturally occurring hormone in the body, can be injected into people to normalize blood glucose levels. Insulin is most commonly used to treat people with diabetes, but it is also used in hospitals to control blood glucose levels in patients. Previous studies of adult intensive care unit (ICU) patients have shown that patients whose blood sugar levels are maintained at normal levels with the use of insulin contract fewer infections and are released more quickly from the ICU than patients who do not maintain normal blood glucose levels. This study will use a continuous blood glucose monitoring system to detect changes in blood glucose levels. Intravenous insulin infusions will be used to then safely maintain normal blood glucose levels. The purpose of this study is to determine if maintaining normal blood glucose levels during an ICU stay will help decrease the incidence of infections and improve surgical recovery in young children following heart surgery.
This study will enroll children who are undergoing heart surgery that requires a cardiopulmonary bypass procedure. Participants will be randomly assigned to either a control group or the treatment group. All participants will receive usual care while in the ICU and will undergo continuous glucose monitoring. Participants in the treatment group will receive intravenous insulin infusions to keep their blood glucose within the normal range. While in the ICU, blood will be collected from all participants once a day for the first 3 days and then once a week to monitor glucose levels, hormone levels, and measurements of nutrition and immune function. On days 1 and 5 following surgery, participants who are on a ventilator will have their breath measured to monitor heart function and energy use. Thirty days and 1 year following surgery, study researchers will contact the participant's parent or doctor to collect information on health status and any new infections at the surgical site. Children who enroll in the study will be asked to participate in follow-up neurodevelopmental evaluations at 1 and 3 years of age to assess longer term cognitive effects of tight glycemic control in the ICU.
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
- None
入排标准
- 年龄范围
- — 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing heart surgery with cardiopulmonary bypass
- •Recovering in the Cardiac ICU
排除标准
- •Enrolled in another interventional clinical trial with related study outcomes
研究组 & 干预措施
Insulin
Insulin was infused to target a blood glucose concentration of 80-110 mg/dL
干预措施: Insulin (Drug)
Usual Care
Insulin was infused according to the discretion of the treating clinical team.
干预措施: Usual Care (Other)
结局指标
主要结局
Incidence of Nosocomial Infections in the Cardiac ICU
时间窗: Measured during participant's ICU stay, a median duration of 3 days.
Nosocomial infections that are attributable to the subject's stay in the Cardiac ICU, according to Center for Disease Control-defined criteria. These definitions are extensive and cannot be accurately condensed to fit within this space. Current CDC/NHSN criteria may be accessed through this URL: https://www.cdc.gov/nhsn/pdfs/pscmanual/17pscnosinfdef_current.pdf.
次要结局
- Cardiac Function(The duration of vasoactive support was evaluated from the day of postoperative cardiac ICU admission until the last day of vasoactive support or day of death from any cause, whichever came first, assessed up to 30 days.)
- Duration of ICU Stay(The duration of cardiac ICU stay was evaluated from the date of postoperative cardiac ICU admission until the date of cardiac ICU discharge or date of death from any cause, whichever came first, assessed up to 30 days.)
- Immune Function(Post-operative day 7.)
- Mortality at 30 Days.(Measured at 30 days.)
- Neurodevelopmental Evaluation, Language(Measured at one year of age.)
- Cardiac Index (CI)(Day 2 (day after cardiopulmonary bypass surgery).)
- Nutritional Status(The percentage of total caloric intake was evaluated from the day of postoperative cardiac ICU admission until the last day of the critical illness period, as defined by the presence of the arterial catheter, assessed up to 30 days.)
- Duration of Hospital Stay(The duration of hospital stay was evaluated from the day of postoperative cardiac ICU admission until the day of hospital discharge or day of death from any cause, whichever came first, assessed up to 30 days.)
- Duration of Endotracheal Intubation(The duration of endotracheal intubation (mechanical ventilation) was evaluated from the day of postoperative cardiac ICU admission until the day of extubation or day of death from any cause, whichever came first, assessed up to 30 days.)
- Mortality at Hospital Discharge.(Mortality at hospital discharge (In-hospital mortality) was evaluated on the day of hospital discharge or day of death from any cause, whichever came first (no upper limit).)
- Endocrine Function(Measured during participant's ICU stay on Day 7.)
- Neurodevelopmental Evaluation, Cognitive(Measured at one year of age.)
- Neurodevelopmental Evaluation, Motor(Measured at one year of age.)
研究者
Michael Agus
Assistant Professor, Harvard Medical School
Boston Children's Hospital