Prevention and Treatment of Common Hyperglycemia in Surgery (PATCHS): A Randomized, Controlled, Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- 30-day Clinical NSQIP-defined serious adverse events
研究概览
简要总结
The PATCH pilot trial aims to establish feasibility and determine the sample size of a future, large-scale, multi-site RCT, as well as reinforce the long-standing known safety profile of glucose, insulin, and potassium (GIK) and explore the physiologic response. We hypothesize that the use of GIK in non-diabetic patients undergoing abdominal surgery, will reduce rates of morbidity & death compared to standard of care treatment. In brief, primary outcomes of interest include estimation of the standard deviation (to derive a sample size estimation) and the ability to recruit target population, assessment of patient compliance/burden, and assessment of provider compliance/burden (feasibility).
详细描述
Elevated glucose levels during surgery are common and dramatically increase the risk of morbidity and mortality. This has been identified in multiple statewide quality improvement collaboratives, with a monotonic relationship between increased glucose levels and higher risks of almost all adverse events. While perioperative glucose management tends to focus on those with diabetes, some degree of perioperative hyperglycemia occurs in as much as two thirds of non-diabetic patients.
A recently identified phenomenon is that, at the same levels of hyperglycemia, non-diabetic patients have a much greater risk of death and complications compared to patients with diabetes. Given that hyperglycemia is typically considered a problem for people with diabetes, this finding has been described as a hyperglycemia paradox. Unfortunately, treatment with insulin can only happen after hyperglycemia has been recognized, and since non-diabetic patients are often not monitored for hyperglycemia, hyperglycemia is likely to be under-recognized. Moreover, addressing hyperglycemia after the fact may not be as effective in reducing adverse events as preventing hyperglycemia.
There is a long history of using perioperative insulin in patients undergoing at least one type of surgery. For over 45 years cardiac anesthesiologists have been testing the benefits of insulin combined with glucose and potassium (GIK) in cardiac surgery. In more than 30 RCTs, including more than 2000 patients with and without diabetes, GIK prophylaxis has been shown to be safe, with < 1 in 200 participants experiencing hypoglycemia secondary to the inclusion of glucose in the formulation. Moreover, these studies have found large reductions in surgically induced inflammation and often significant improvements in clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Adults 18 years of age or older
- •Patients undergoing abdominal surgery planned to last greater than 4 hours with inpatient admission
- •Patients at UWMC - Montlake
- •3. Makes their own medical decisions: patient is deemed to have decisional capacity by the medical team and does not have a surrogate such as a spouse, partner, or caretaker making the decision on their behalf. Examples include patients with severe dementia or other cognitive limitations
排除标准
- •Known diagnosis of diabetes or altered glucose homeostasis during preoperative evaluation (single fasting blood sugar≥126 mg/dL or HbA1C≥6.5 percent).
- •Known diagnosis of chronic kidney disease (moderate-to-severe, or worse)
- •BMP within 6 months of screening is required. Patients with stage 3b (moderate-to-severe) kidney disease or worse (i.e. eGFR ≤ 30) will be excluded. Patients with a potassium reading greater than 5.5 at any point within the 6-month period will also be excluded.
- •Patients receiving chronic systemic steroids.
- •Patients undergoing cardiac or solid organ transplant procedures.
- •Surgery planned to last less than 4 hours.
- •Outpatient surgery
- •Pregnant people
- •Current UW Medicine or UW Dentistry residents and fellows
- •Known hypersensitivity to potassium, glucose, insulin, or any of its excipients.
- •Enrollment in another therapeutic study
- •Any serious underlying medical or psychiatric condition, dementia, altered mental status or any issue that would impair the ability of the patient to receive or tolerate the planned treatment, to understand informed consent or that in the opinion of the investigator would contraindicate the patient's participation in the study or that would confound the results of the study.
研究组 & 干预措施
Standard Care
Subjects in the standard care/placebo arm will receive only regular crystalloid.
干预措施: Crystalloid Infusion (Drug)
GIK
Subjects in the glucose, insulin, and potassium (GIK) arm will receive regular crystalloid with GIK added.
干预措施: glucose, insulin, and potassium (GIK) (Drug)
GIK
Subjects in the glucose, insulin, and potassium (GIK) arm will receive regular crystalloid with GIK added.
干预措施: Crystalloid Infusion (Drug)
结局指标
主要结局
30-day Clinical NSQIP-defined serious adverse events
时间窗: 30 days
Estimate the standard deviation in support of anticipated, large-scale RCT for the outcome 30-day Clinical NSQIP-defined serious adverse events
Patient compliance/burden
时间窗: 1 day
Number patient refusal events vs enrolled
Ability to recruit the target population
时间窗: 1 day
Number of patients screened per month vs number of patients enrolled per month
Provider compliance/burden
时间窗: 1
Number of times GIK stopped for 20 minutes
Safety
时间窗: 1 day
Number of AEs and SAEs, thought to be at least possibly related to treatment, as well as associated AE type
次要结局
- Number of hyperglycemic and hypoglycemic events(1 day)
- Length of stay in hospital(30 days)
研究者
David Flum
Professor, Division of General Surgery
University of Washington