Diabetes Cardiac Surgery Initiative (DCI): A Community Based Pre-cardiac Surgery Diabetes Care Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- Change in A1C over the study period.
研究概览
简要总结
The Canadian Diabetes Association recommends optimizing glycemic control to achieve a glycated hemoglobin (A1C) of less than 7% in patients with diabetes. Despite these recommendations, approximately 25% of patients undergoing cardiac surgery have evidence of suboptimal glycemic control (A1C>7%). Recent research has demonstrated that such patients experience a higher rate of post-operative complications and significantly worse short-term and long-term post-operative survival. Therefore, it is recommended that attempts should be made to improve glycemic control while patients wait for their elective surgery. However, at present processes of care that facilitate pre-operative glycemic control optimization do not exist in Canada.
The objective of this project is to determine the feasibility and effectiveness of a comprehensive community-based pre-operative diabetes optimization program for patients awaiting elective cardiac surgery.
详细描述
This study is a randomized controlled trial and will investigate the feasibility and effectiveness of a pre-operative diabetes optimization program for patients with suboptimal glycemic control awaiting elective cardiac surgery. Consenting patients will be randomized to a Standard Pre-Operative Diabetes Care Group (Group 1) and a Structured Pre-Operative Diabetes Optimization Group (Group 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Able to speak and understand English
- •Age > 18
- •Able to provide informed consent
- •Placed on the waiting list for elective cardiac surgery in Manitoba
排除标准
- •Progressive cognitive deficit or disease.
- •Age < 18
- •Unable to provide informed consent
- •Undergoing emergent cardiac surgery
研究组 & 干预措施
Group 1
Group 1 - Standard Pre-operative Diabetes Care
Group 2
Group 2 - Structured Pre-operative Diabetes Optimization
干预措施: Structured Pre-operative Diabetes Optimization (Other)
结局指标
主要结局
Change in A1C over the study period.
时间窗: Baseline to the patients' 3-months post-operative appointment
次要结局
- Changes in the patient perioperative outcomes(Baseline to the patients' 3-months post-operative appointment)
- Changes to the responses on the validated patient surveys(Baseline to the patients' 3-months post-operative appointment)
研究者
Dr. Rakesh C. Arora
Medical Director, Intensive Care Cardiac Sciences
St. Boniface Hospital