- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02460211
Acute Effect of Systemic Stress on Measured Blood Concentrations of 25 (OH) Vitamin D (ASSESS-D)
2021년 4월 1일 업데이트: Intermountain Health Care, Inc.
Each patient who is admitted for preoperative preparation for elective open heart surgery at Intermountain Medical Center will be invited to participate in this study.
After a written informed consent is obtained, patients meeting inclusion/exclusion criteria will be randomized 1:1 to the treatment arm or placebo/control arm.
Those randomized to the treatment arm will receive three 50,000 unit oral doses of vitamin D3 supplementation.
The first dose will be given the evening before surgery.
The second and third doses will be given either orally or per NG tube on the mornings of post-op days 1 and 2. Blood will be obtained at the following time periods: 1) At baseline pre-procedure 12 to 18 hours before planned surgery; 2) Post-operative day 1, 12 to 24 hours after surgery; 3) 48 hours after surgery; 4) 72 hours after surgery; 5) At discharge (estimated to be between 5-8 days after surgery); and 6) At the 6-month follow-up visit (post-surgery).
Plasma levels of 25(OH) vitamin D will be measured on each sample.
연구 개요
상세 설명
Each patient who is admitted for preoperative preparation for elective open heart surgery at Intermountain Medical Center will be invited to participate in this study.
The patient's history and medical records will be reviewed and data gathered will be used to evaluate the patient's relationship to inclusion and exclusion criteria.
After a written informed consent is obtained, subjects will be randomized 1:1 to the treatment arm or placebo/control arm.
Those randomized to the treatment arm will receive three 50,000 unit oral doses of vitamin D3 supplementation.
The first dose will be given the evening before surgery.
The second and third doses will be given either orally or per NG tube on the mornings of post-op days 1 and 2. Approximately 15-20 ml (about one tablespoon) of blood will be obtained at the following time periods (+/- 4 hours): 1) At baseline pre-procedure 12 to 18 hours before planned surgery; 2) Post-operative day 1, 12 to 24 hours after surgery; 3) 48 hours after surgery; 4) 72 hours after surgery; 5) At discharge (estimated to be between 5-8 days after surgery); and 6) At the 6-month follow-up visit (post-surgery).
Each blood sample will be transported to The Center for Molecular and Genetic Research at LDS Hospital Cardiovascular Genetics Laboratory for preparation and storage.
Plasma levels of 25(OH) vitamin D will be measured on each sample.
연구 유형
중재적
등록 (실제)
150
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Utah
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Murray, Utah, 미국, 84143
- Intermountain Heart Institute
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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 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Male or female >= 18 years of age
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures
- Subject is scheduled for elective open heart surgery at Intermountain Medical Center
- Subject is relatively stable as assessed by the Principal Investigator
Exclusion Criteria:
- Inability or refusal of the patient and/or the patient's legally acceptable representative to provide written informed consent for any reason.
- History of previous vitamin D supplementation > 1,000 units of vitamin D3 per day within the past three months.
- Evidence of hypercalcemia on screening labs (> 10.5 milligrams per deciliter of blood).
- Any scheduled cardiac surgical procedure that does not require open thoracotomy (the reason for this exclusion is that the study design requires that the patients will undergo a significantly stressful procedure, which can be generally guaranteed if the patient undergoes open thoracotomy).
- Known allergic reaction or other intolerance to oral vitamin D3.
- Pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Principal Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
- Subject participation in previous investigational interventional studies within 30 days of the current study.
- Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
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: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Treatment
Those randomized to the treatment arm will receive three 50,000 unit oral doses of vitamin D3 supplementation.
|
Those randomized to the treatment arm will receive three 50,000 unit oral doses of vitamin D3 supplementation.
The first dose will be given the evening before surgery.
The second and third doses will be given either orally or per NG tube on days 1 and 2 after surgery.
|
|
위약 비교기: Placebo/Control Arm
Those randomized to the control arm will receive three oral placebo doses.
|
Those randomized to the control arm will receive three placebo doses.
The first dose will be given the evening before surgery.
The second and third doses will be given either orally or per NG tube on days 1 and 2 after surgery.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Changes in 25(OH) vitamin D levels (ng/ml) between baseline (pre-surgery) and 72 hours post-surgery.
기간: 72 hours
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72 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Comparison of 25(OH) vitamin D levels (ng/ml) between baseline and other time points.
기간: 12-24 hrs, 48 hrs, discharge (approximately 5-8 days post-surgery), 6 months
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Subjects will be re-assessed on post-operative day 1 (12-24 hours after surgery), then at 48 and 72 hours post-surgery, at discharge (approximately 5-8 days post-surgery), and at a 6 month post-surgery follow-up visit.
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12-24 hrs, 48 hrs, discharge (approximately 5-8 days post-surgery), 6 months
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Percent differences in adverse clinical outcomes between the vitamin D3 supplementation treatment and placebo arms.
기간: 6 months
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Clinical outcomes that will be monitored include: death, myocardial infarction, stroke, repeat coronary revascularization or hospitalization for heart failure, worsening of renal function, hospitalization for pneumonia or other acute systemic infection or any other serious adverse clinical event.
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6 months
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Time to adverse clinical events stratified by vitamin D3 supplementation and placebo arms.
기간: 6 months
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Clinical outcomes that will be monitored include: death, myocardial infarction, stroke, repeat coronary revascularization or hospitalization for heart failure, worsening of renal function, hospitalization for pneumonia or other acute systemic infection or any other serious adverse clinical event.
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6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Joseph B Muhlestein, MD, Intermountain Health Care, Inc.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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 (실제)
2015년 7월 1일
기본 완료 (실제)
2018년 10월 1일
연구 완료 (실제)
2020년 10월 1일
연구 등록 날짜
최초 제출
2015년 4월 8일
QC 기준을 충족하는 최초 제출
2015년 5월 29일
처음 게시됨 (추정)
2015년 6월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 4월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 4월 1일
마지막으로 확인됨
2021년 4월 1일
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. .
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