Prospective, Observational Study Evaluating the Glycemic Control Based on Serum Fructosamine Concentration vs. hemoglobinA1c (HbA1c) in Diabetic Patients Undergoing Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- fasting capillary blood glucose level
研究概览
简要总结
Diabetes mellitus is associated with negative outcomes in patients undergoing surgery. Blood sugar levels are monitored by measuring a values that include but are not limited to hemoglobin A1c, capillary blood glucose, and fructosamine . This study is being done to investigate if there is an associated between these values and postsurgical outcomes.
详细描述
This study aims to compare the predictive capacity of both fructosamine and HbA1c on preoperative basal glucose level, as well as adverse events (cardiovascular events, surgical site infection, and mortality) and length of post-anesthesia care unit (PACU) stay in both Type I and Type II diabetic patients. Secondary outcomes include length of anesthesia administration, an indicator of intraoperative complications, and perioperative glucose level.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Male or female patients able to consent.
- •Patients with either Type I or Type II diabetes mellitus (DM)
- •Patients undergoing non-cardiac surgeries under general anesthesia
- •≥ 18 years of age
排除标准
- •Inability to read, understand or sign the consent form
- •End-stage renal disease
- •Special populations (Incarcerated individuals, pregnant female patients)
结局指标
主要结局
fasting capillary blood glucose level
时间窗: 1 hour
Association between pre-operative HbA1c and fructosamine with pre-operative, fasting capillary blood glucose level measured the morning of surgery in preoperative holding area.
次要结局
- wound healing(1 day)
- infection(1 day)
- reoperation(1 day)
- delirium(1 day)
- LOS(1 day)
- hypoglycemia(1 day)
- hyperglycemia(1 day)
研究者
Barbara Rogers
Associate Professor
Ohio State University