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Effects of Hyperglycemia During Cardiopulmonary Bypass on Renal Function

To determine whether intraoperative hyperglycemia potentiates renal injury in the setting of cardiac surgery requiring cardiopulmonary bypass.

研究概览

地位

完全的

详细说明

Significance:

Postoperative renal dysfunction is a common complication of cardiopulmonary bypass occurring in nearly 8% of all patients undergoing myocardial revascularization. Both diabetes and preoperative hyperglycemia are independent risk factors for postoperative renal dysfunction after coronary artery bypass surgery.

The cause of renal injury is multifactoral and in most cases involves renal ischemia from alteration of renal perfusion, resistance, metabolic byproducts (free-radical species), inflammatory mediators and embolic processes.

In the setting of ischemia, specifically, neuronal, hyperglycemia has been shown to worsen neurologic outcome and interfere with wound healing-possibly increasing the incidence of wound infection.

Hyperglycemia is common during cardiopulmonary bypass in both diabetic and non-diabetic patients as a result of altered glucose regulation during hypothermic conditions (body temperature actively cooled to 28 degree centigrade) and, more importantly, from delivery of cardioplegia to arrest the heart allowing for surgical repair in a non-beating heart. The cardioplegia is rich in potassium, among other agents, believed to offer cardioprotection during cardiopulmonary bypass and is prepared in Dextrose 5% and normal saline. On average, each patient receives nearly 2 liters of this solution, amounting to 100 grams or more of glucose. In this setting, hyperglycemia is also promoted from insulin suppression, stress hormone induced gluconeogenesis and enhanced tubular resorption.

Only recently have perioperative clinicians become aware about potential ischemic effects of hyperglycemia during bypass and the need to maintain 'tight' control of glucose to avoid stroke. This practice, however, is inconsistent and mostly applied to diabetic patients.

We hypothesize that tubular injury may be exacerbated by hyperglycemia in non-diabetic patients while undergoing hypothermic cardiopulmonary bypass and have undertaken this prospective observational study to investigate the relationship between intraoperative glucose and postoperative renal dysfunction.

Methodology:

We plan to study to 200 patients ≥ 50 years of age scheduled for procedures requiring cardiopulmonary bypass whether for coronary revascularization or valvular surgery. After informed consent is obtained each patient's preoperative lab values consisting of serum glucose, urine glucose, creatinine and BUN will be noted. Each patient's pre-induction hemodynamics will also be noted. During bypass, serum and urine glucose will be measured every 20 minutes in addition to collecting information on temperature of cardioplegic solution, lowest patient temperature, time of bypass, and use of diuretics, or vasoactive drugs. Additional sampling of serum creatinine and glucose and vital signs will take place upon arrival in the cardiac intensive care unit after surgery and throughout hospitalization as is standard of care in cardiac surgery at this institution. No extra samples will be taken but the standard measurements will be observed. The clinical outcome of interest is a new onset of renal dysfunction defined as a post-operative serum creatinine change of 0.5 mg/dl or greater after surgery.

Inclusion Criteria:

  1. Male and female patients ≥ 50 years of age
  2. Patients undergoing on pump cardiopulmonary bypass for either myocardial revascularization (coronary artery bypass graft) or valvular surgery (valve repair or replacement)

Exclusion Criteria:

  1. Patients with insulin dependent diabetes
  2. Patients with preexisting renal dysfunction defined as Creatinine> 2 mg/dl
  3. Patients in need of emergency cardiac procedures

研究类型

观察性的

注册 (实际的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • New York、New York、美国、10021
        • The New York Presbyterian Hospital - Weill Medical College of Cornell University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients undergoing on pump cardiopulmonary bypass for either myocardial revascularization (coronary artery bypass graft) or valvular surgery (valve repair or replacement)

描述

Inclusion Criteria:

  1. Male and female patients ≥ 50 years of age
  2. Patients undergoing on pump cardiopulmonary bypass for either myocardial revascularization (coronary artery bypass graft) or valvular surgery (valve repair or replacement)

Exclusion Criteria:

  1. Patients with insulin dependent diabetes
  2. Patients with preexisting renal dysfunction defined as Creatinine> 2 mg/dl
  3. Patients in need of emergency cardiac procedures

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Paul Heerdt, MD, PhD、Associate Professor

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2005年7月1日

初级完成 (实际的)

2010年10月1日

研究完成 (实际的)

2012年7月1日

研究注册日期

首次提交

2006年11月28日

首先提交符合 QC 标准的

2006年11月28日

首次发布 (估计)

2006年11月29日

研究记录更新

最后更新发布 (估计)

2017年2月6日

上次提交的符合 QC 标准的更新

2017年2月2日

最后验证

2017年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 0408007400

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

Will not share

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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