- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01361594
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
상태
완전한
정황
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
-
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Georgia
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Atlanta, Georgia, 미국, 30326
- Emory University Hospital
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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:
- Males or females between the ages of 18 and 80 years undergoing CABG +/- valve surgery.
- Post surgical hyperglycemia (BG > 140 mg/dl).
- Patients with and without a history of type 2 diabetes
Exclusion Criteria:
- Patients requiring combination CABG with additional procedures such aorta replacement.
- Patients with severely impaired renal function (serum creatinine ≥3.0 mg/dl or GFR < 30 ml/min) or clinically significant hepatic failure.
- Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
- Moribund patients and those at imminent risk of death (brain death or cardiac standstill).
- 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.
- 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
|
|
average 1 month during the hospitalization
|
Major Cardiovascular Events
기간: average 1 month during the hospitalization
|
|
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
|
|
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
추가 관련 MeSH 약관
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. .