The Effect of Insulin-Glucose Infusion on Metabolic Control (Primary) and Inflammation (Secondary) in Diabetic Patients Treated for Acute Foot Ulcer Infection or Surgical Wound Infection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Plasma glucose level.
研究概览
简要总结
Normoglycemia is important for the outcome of surgical and medical conditions. Insulin infusions have been studied to achieve normoglycemia during these circumstances and have proved to be useful. Insulin given by subcutaneous injections has longer duration compared to intravenous given insulin which makes it more difficult to control. The hypothesis behind the trial is the concept that insulin infusion is more effective in reaching normoglycemia in diabetic subjects during foot ulcer infection and surgical wound infection.
- The study evaluates a target controlled insulin infusion or conventional therapy as antidiabetic treatment during foot ulcer infection and surgical wound infection.
- Secondary efficacy parameter will be hospital stay, laboratories for inflammation and oxidative stress.
详细描述
Introduction:
Normoglycemia is important for the outcome of acute surgical and medical conditions. Different insulin infusions have been studied to achieve normoglycemia and have proved to be useful. Insulin given by subcutaneous injections has duration between 3- 36 hours depending on the insulin brand and injection site compared to 10 minutes for intravenous given insulin. Different insulin infusions have been studied to achieve normoglycemia but the biological and chemical effects of insulin infusions have not been studied during foot ulcer infection and surgical wound infection in patients with diabetes. Therefore, we aim to investigate the importance of normoglycemia for the optimal treatment during foot ulcer infection and surgical wound infection among diabetics.
Hypothesis:
Target controlled insulin infusion is more effective in reducing hyperglycemia, improve healing of inflammation and infection in diabetics compared to conventional antidiabetic therapy.
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Patients are eligible for inclusion if the following criteria are fulfilled:
- •Postoperative or infectious patients with: skin-, airways-, urine tract- or gastro-intestinal infections.
- •Hyperglycaemia: Capillary P-glucose above 8 mmol/L.
- •Older than 18 years.
- •Informed consent obtained.
排除标准
- •Patients having any of the following at randomization will not be included in the study:
- •Unconsciousness: not possible to wake up.
- •Ketoacidosis: pH less or equal to 7.
- •Hyperosmolar syndrome: S-Na more or equal to 150 mmol/L.
- •Kidney failure: calculated GFR < 30 mL/min.
- •Pregnancy.
- •Mental condition making the subject unable to understand the concepts and risk of the study.
结局指标
主要结局
Plasma glucose level.
时间窗: 4 weeks
次要结局
- HbA1c(4 weeks)
- laboratories for inflammation and oxidative stress.(4 weeks)
- Hospital stay(4 weeks)