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Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery (CABG)

2014年12月18日 更新者:Guillermo Umpierrez、Emory University
High blood glucose levels (hyperglycemia) in cardiac surgery patients with diabetes are associated with increased risk of hospital complications. Blood sugar control with intravenous insulin may prevent such hospital complications. Many patients undergoing cardiac bypass surgery (CABG) develop high blood sugars and require insulin therapy (shortly before or after surgery). It is not clear what the best insulin regimen is or what is the best blood sugar target in these patients. Accordingly, this research study aims to determine optimal blood glucose levels during the in patients undergoing cardiac bypass surgery. Patients will be divided in two groups. The intensive insulin group will be maintained at blood glucose between 100-140 mg/dl and the conventional treatment group at a glucose level between 140-180 mg/dl. The insulins to be used in this trial (lantus, aspart and regular insulin) are approved for use in the treatment of patients with diabetes by the FDA (Food and Drug Administration). A total of 326 patients with high blood glucose after cardiac bypass surgery will be recruited in this study. Patients will be recruited at Emory University Hospital, Emory Midtown Hospital and Grady Memorial Hospital.

調査の概要

詳細な説明

Several prospective cohort studies as well as randomized clinical trials (RCT) in cardiac surgery patients have shown that intensified insulin therapy (target BG: 110-140 mg/dl) results in a reduction in short- and long-term mortality compared with conventionally treated patients. The results of recent international trials in critically ill patients; however, have failed to show a significant improvement in mortality or have even shown increased mortality risk as well as increased number of hypoglycemic events with intensive compared to less intensive glycemic control. Based on the results of these ICU trials, new ADA and AACE guidelines recommended a glycemic target between 140 and 180 mg/dl in the ICU including cardiac surgery patients. There is concern that such high BG targets might increase the risk of hospital complications in cardiac surgical patients in whom intensive glucose control has consistently reduced infections, length of hospital stay, resource utilization, and cardiac-related mortality. The overall objective of this proposal is to conduct the first prospective RCT to determine the optimal BG target during the perioperative period in hyperglycemic subjects who undergo CABG in the United States. Subjects will be randomized to undergo intensive insulin therapy adjusted to maintain a BG between 100 mg/dl and 140 mg/dl or to a conventional glucose control with a target BG between 141 mg/dl and 200 mg/dl in the ICU. The central hypothesis of this proposal is that intensive insulin management will reduce perioperative complications compared to a conventional BG control in cardiac surgery patients.

研究の種類

介入

入学 (実際)

338

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Georgia
      • Atlanta、Georgia、アメリカ、30326
        • Emory University Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~80年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Males or females between the ages of 18 and 80 years undergoing CABG +/- valve surgery.
  2. Post surgical hyperglycemia (BG > 140 mg/dl).
  3. Patients with and without a history of type 2 diabetes

Exclusion Criteria:

  1. Patients requiring combination CABG with additional procedures such aorta replacement.
  2. Patients with severely impaired renal function (serum creatinine ≥3.0 mg/dl or GFR < 30 ml/min) or clinically significant hepatic failure.
  3. Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
  4. Moribund patients and those at imminent risk of death (brain death or cardiac standstill).
  5. Patients or next-to-kin with mental condition rendering the subject or family member unable to understand the nature, scope, and possible consequences of the study.
  6. Female subjects who are pregnant or breast-feeding at time of enrollment into the study.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:Intensive insulin treatment
Intensive insulin treatment (BG target: 100-140 mg/dL)
Titration of the IV insulin rate for glucose goal 100-140 mg/dL
アクティブコンパレータ:Conventional insulin treatment
Conventional insulin treatment (BG target: 141-180 mg/dl)
Titration of the IV insulin rate for glucose goal 141-180 mg/dl

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of Subjects That Were Diagnosed for Peri-operative Complications
時間枠:Within 6 months of hospitalization
Number of participants that presented at least 1 complications including sternal wound infection, bacteremia, acute renal failure, respiratory failure, and major cardiovascular events (MACE) during the current hospitalization and up to 6 months after hospitalization
Within 6 months of hospitalization
Hospital Mortality
時間枠:average 1 month during the hospitalization
Mortality is defined as death occurring during admission, either during ICU or after transition to non-ICU admission.
average 1 month during the hospitalization

二次結果の測定

結果測定
メジャーの説明
時間枠
Glycemic Control
時間枠:average 1 month during the hospitalization
  1. Hyperglycemic events (BG > 200 mg/dL) in ICU and non-ICU
  2. Hypoglycemic events (BG < 70 mg/dl; severe hypoglycemia (BG < 40 mg/dl).
average 1 month during the hospitalization
Major Cardiovascular Events
時間枠:average 1 month during the hospitalization
  1. Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).
  2. Congestive heart failure
  3. Cardiac arrhythmias: malignant arrhythmia
average 1 month during the hospitalization
Acute Renal Failure
時間枠:average 1 month during the hospitalization
new-onset abnormal renal function: serum creatinine > 2.0 mg/dL or an increment level > 50% from baseline
average 1 month during the hospitalization
Respiratory Failure, Defined as PaO2 Value < 60 mm Hg While Breathing Air or a PaCO2 > 50 mm Hg.
時間枠:average 1 month during the hospitalization
Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg.
average 1 month during the hospitalization
ICU and Hospital Length of Stay, and ICU Readmissions
時間枠:average 1 month during the hospitalization
ICU and hospital length of stay, and ICU readmissions
average 1 month during the hospitalization
Surgical Wound Infection
時間枠:average 1 month during the hospitalization
superficial and deep sternal wound infection
average 1 month during the hospitalization
Pneumonia (CDC Criteria)
時間枠:average 1 month during the hospitalization
Pneumonia (CDC criteria)
average 1 month during the hospitalization
Cerebrovascular Events
時間枠:average 1 month during the hospitalization
permanent stroke and reversible ischemic neurologic deficit.
average 1 month during the hospitalization
Duration of Ventilatory Support and ICU Readmission
時間枠:average 1 month during the hospitalization
Duration of ventilatory support and ICU readmission
average 1 month during the hospitalization
Thirty Day Mortality
時間枠:within 30 days of discharge
Thirty day mortality
within 30 days of discharge
Number of Hospital Readmissions and Emergency Room Visits
時間枠:Within 30 days after discharge
Number of hospital readmissions and emergency room visits
Within 30 days after discharge
Incidence of Organ Failures Assessed by the Daily SOFA Score
時間枠:average 1 month during the hospitalization
Incidence of organ failures assessed by the daily SOFA score
average 1 month during the hospitalization
Measures of Inflammation
時間枠:average 1 month during the hospitalization
Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers
average 1 month during the hospitalization
Major Cardiovascular Events
時間枠:within 3 months after discharge
  1. Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).
  2. Congestive heart failure
  3. Cardiac arrhythmias: malignant arrhythmia
within 3 months after discharge
Surgical Wound Infection
時間枠:within 3 months after discharge
Superficial and deep sternal wound infection
within 3 months after discharge
Pneumonia (CDC Criteria)
時間枠:Within 3 months after discharge
Pneumonia (CDC criteria)
Within 3 months after discharge
Cerebrovascular Events
時間枠:within 3 months after discharge
permanent stroke and reversible ischemic neurologic deficit
within 3 months after discharge

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Guillermo E Umpierrez, MD、Emory University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2011年6月1日

一次修了 (実際)

2013年12月1日

研究の完了 (実際)

2013年12月1日

試験登録日

最初に提出

2011年2月3日

QC基準を満たした最初の提出物

2011年5月26日

最初の投稿 (見積もり)

2011年5月27日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年12月31日

QC基準を満たした最後の更新が送信されました

2014年12月18日

最終確認日

2014年12月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • IRB00048356
  • 00048356-2010 (その他の識別子:Other)

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