- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01211730
Study of Glycemic Control on Liver Transplantation Outcomes
Prospective, Randomized, Open-Label, Controlled Study to Evaluate the Safety and Efficacy of Intensive Glycemic Control on Outcomes Following Liver Transplantation
연구 개요
상세 설명
Many studies have shown improvement in morbidity and mortality with intensive glycemic management postoperatively. However, some recent studies have not been able to reproduce these benefits and have raised the issue of adverse consequences of hypoglycemia associated with intensive therapy. Our own data show an association of increased graft rejection proportional to postoperative glucose levels in patients who have undergone a liver transplant. Preliminary data suggest that this may improved by better glycemic control using the Glucose Management Service here at Northwestern.
In this study, we propose to determine whether improved glycemic control using intensive insulin treatment immediately postoperatively will improve outcomes in patients undergoing liver transplant using a prospective, controlled, randomized, parallel-group study design targeting two different glucose levels, 140 and 180 mg/dL. Postoperative glucose management with insulin will be supervised by the Glucose Management Service as is routine, with the only research aspect being the two different glucose targets and the outcome analysis with liver transplant rejection as the primary outcome and infections and hypoglycemia being the principle secondary outcomes.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern University Feinberg School of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Require Liver Transplantation
- Age 18 - 80
- Able to give informed consent personally or via a family member who has appropriate authorization to do so if patient unconscious.
- Expected survival following transplantation for > 1 year.
- Glucose level over 180 mg/dL postoperatively
Exclusion Criteria:
- Inability of patient or family member to give informed consent
- Not expected to survive for > 1 year following liver transplantation.
- Previous liver transplantation
- Acute liver failure
- Living related donor
공부 계획
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: 140 Group
Insulin treatment to target blood glucose at 140 mg/dl
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Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
다른 이름들:
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활성 비교기: 180 Group
Insulin treatment to target blood glucose at 180 mg/dl
|
Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rejection of Liver Transplant
기간: within 1 year of transplantation
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Liver transplant rejection determined by either biopsy or clinical criteria (>2x transaminases, clinical decision, treatment with high dose steroids and other anti-rejection medications
|
within 1 year of transplantation
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Hypoglycemia
기간: Within first 3 days following transplantation
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Participants experiencing hypoglycemia (glucose < 70 mg/dL) within the first 3- days following transplantation
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Within first 3 days following transplantation
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|
Infection Rates
기간: Within 1 year following transplantation
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Within 1 year following transplantation
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Rehospitalization Rates
기간: Within 1 year following transplantation
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Within 1 year following transplantation
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Overall Graft Survival at 1 Year
기간: 1 year following transplantation
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1 year following transplantation
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Death Within 1 Year
기간: 1 year
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Death following liver transplant between 1 day and 1 year
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1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mark E Molitch, M.D., Northwestern University Feinberg School of Medicine
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .