- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01532505
Effect of Vasopressin on Tissue Oxygen Saturation in Cardiac Surgery Patients During Cardiopulmonary Bypass
A Randomized Study Comparing Low Dose Vasopressin Infusion or Placebo on Near Infrared Spectroscopy Tissue Oxygen Saturation and the Vascular Occlusion Test in Cardiac Surgery Patients During Cardiopulmonary Bypass: A Pilot Study
연구 개요
상세 설명
In our double blind randomized study 40 patients undergoing cardiac surgery will be randomly divided in two groups. The group A who will be infused with 2 IU/hr. vasopressin and the group B who will be infused with normal saline (placebo) intraoperatively starting at the time we give I.V. Heparin, throughout CPB and infusion will be ended when we give the Protamine after coming off bypass. VOTs will be measured at the following time points: Pre-induction of anesthesia, post-induction of anesthesia and at 30 minute intervals during the cardiopulmonary bypass. And we will select cases that are expected to have a longer CPB time such as Redo CABG, CABG + valve replacement, double valve replacement, Bentall procedure and Mitral valve repair with mini thoracotomy.
Measurements of mean artery pressure (MAP), central venous pressure (CVP), ejection fracture (EF), heart rate (HR), mean pulmonary artery pressure (MPAP), cardiac index (CI) will be performed before, during, and after the operation. The requirements of catecholamine support (eg. phenylephrine, epinephrine, vasopressin, norepinephrine, and dopamine) during CPB and for first 24 hours postoperatively, urine-output, blood-loss, and the requirements in blood, plasma and platelets for the first 24 hours will be included in the data collected.
The purpose of the present study is to quantify the micro-oxygenation parameters in patients undergoing cardiac surgery with CPB, to investigate the relationship of micro-oxygenation and macro-perfusion parameters, to investigate the relationship of NIRS parameters and to evaluate the association between micro-oxygenation parameters and outcome using VOT and comparing the degree of falling of re-perfusion slope.
We hypothesize that the administration of a low dose vasopressin will reduce both the incidence and severity of vasoplegia and it will maintain the normal vasomotor reactivity during cardiopulmonary bypass and this will reduce the total requirements of alpha-adrenergic agonists specially Phenylephrine. That will reduce the risks of the use of high dose of Phenylephrine and other inotropes, such as gut ischemia and end organ damage.
Vascular Occlusion Test (VOT)
- After the tissue oximetry probe is applied to the skin the oximeter machine records a baseline value.
- A pneumatic cuff (blood pressure cuff) is placed over the brachial artery of the same arm above the elbow and inflated to 50 mmHg above systolic blood pressure. The cuff remains inflated for 5 minutes. The oximeter machine is continuously recording StO2 values and other pertinent technical information such as quality of the signal and events marked by the user.
- After 5 minutes the cuff is quickly deflated and StO2 measurements continue to be recorded until back to baseline.
- VOTs will be measured at the following time points:
- Pre-induction of anesthesia
- Post-induction of anesthesia
- At 30 minute intervals during the cardiopulmonary bypass
Several measurements and calculations will be made from the recorded data:
- Baseline tissue oxygen saturation (StO2baseline) at time (t) = 0
- Lowest StO2 reached after vascular occlusion (StO2nadir) and at what time
- Occlusion slope: defined as = (StO2baseline - StO2nadir/tbaseline - tnadir)
- After cuff release, time at which baseline StO2 was reached (StO2recovery)
- Reperfusion slope: defined as = (StO2recovery - StO2nadir/trecovery - tnadir)
- ∆StO2: defined as = (StO2peak - StO2baseline)
- Peak StO2 reached after cuff release and at what time
Measurements of mean artery pressure (MAP), central venous pressure (CVP), ejection fracture (EF), heart rate (HR), mean pulmonary artery pressure (MPAP), cardiac index (CI) will be performed before, during, and after the operation. The requirements of catecholamine support (eg. phenylephrine, epinephrine, vasopressin, norepinephrine, dopamine) during CPB and for first 24 hours postoperatively, urine-output, blood-loss, and the requirements in blood, plasma and platelets for the first 24 hours will be included in the data collected.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Ontario
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London, Ontario, 캐나다, N6A 5A5
- University Hospital, LHSC
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Adult, elective cardiac surgery patients with the use of cardiopulmonary bypass (CPB)
Exclusion Criteria:
- Age less than 18 years
- Contraindication to pneumatic cuff inflation (arteriovenous fistula, previous mastectomy, injury to arm)
- Pregnancy
- Significant peripheral vascular disease of the arms*
- Emergency surgery
- Uncured cancer during chemotherapy
- Lack of informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
VOT assessment of microcirculation
기간: day one
|
change in reperfusion slope of VOT will be assessed each 30 min during CPB and compared between vasopressin and placebo patients
|
day one
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: MOHAMED ISMAIL, MD,MSc, London HSC
- 연구 책임자: JOHN MURKIN, MD, FRCPC, London HSC
간행물 및 유용한 링크
일반 간행물
- Peripheral Tissue Oxygen Saturation (SaO2) Monitoring and the Vascular Occlusion Test in Cardiac Surgery: A Pilot Study. Smith R, Murkin J, Granton J, Guo LR, McKenzie FN, Min F, Zhang R. ASA Chicago, Oct 15-19, 2011, Anesthesiology 2011 A278.
- Papadopoulos G, Sintou E, Siminelakis S, Koletsis E, Baikoussis NG, Apostolakis E. Perioperative infusion of low- dose of vasopressin for prevention and management of vasodilatory vasoplegic syndrome in patients undergoing coronary artery bypass grafting-A double-blind randomized study. J Cardiothorac Surg. 2010 Mar 28;5:17. doi: 10.1186/1749-8090-5-17.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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
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