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

2014년 12월 18일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

338

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Georgia
      • Atlanta, Georgia, 미국, 30326
        • Emory University Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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
활성 비교기: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Subjects That Were Diagnosed for Peri-operative Complications
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Glycemic Control
기간: 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
기간: 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
기간: 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.
기간: 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
기간: average 1 month during the hospitalization
ICU and hospital length of stay, and ICU readmissions
average 1 month during the hospitalization
Surgical Wound Infection
기간: average 1 month during the hospitalization
superficial and deep sternal wound infection
average 1 month during the hospitalization
Pneumonia (CDC Criteria)
기간: average 1 month during the hospitalization
Pneumonia (CDC criteria)
average 1 month during the hospitalization
Cerebrovascular Events
기간: 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
기간: average 1 month during the hospitalization
Duration of ventilatory support and ICU readmission
average 1 month during the hospitalization
Thirty Day Mortality
기간: within 30 days of discharge
Thirty day mortality
within 30 days of discharge
Number of Hospital Readmissions and Emergency Room Visits
기간: 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
기간: 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
기간: 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
기간: 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
기간: within 3 months after discharge
Superficial and deep sternal wound infection
within 3 months after discharge
Pneumonia (CDC Criteria)
기간: Within 3 months after discharge
Pneumonia (CDC criteria)
Within 3 months after discharge
Cerebrovascular Events
기간: within 3 months after discharge
permanent stroke and reversible ischemic neurologic deficit
within 3 months after discharge

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Guillermo E Umpierrez, MD, Emory University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2011년 6월 1일

기본 완료 (실제)

2013년 12월 1일

연구 완료 (실제)

2013년 12월 1일

연구 등록 날짜

최초 제출

2011년 2월 3일

QC 기준을 충족하는 최초 제출

2011년 5월 26일

처음 게시됨 (추정)

2011년 5월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 12월 31일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 12월 18일

마지막으로 확인됨

2014년 12월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • IRB00048356
  • 00048356-2010 (기타 식별자: Other)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Regular insulin (intensive treatment)에 대한 임상 시험

3
구독하다