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
研究概览
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Ontario
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London、Ontario、加拿大、N6A 5A5
- University Hospital, LHSC
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接触:
- Mohamed Ismail, MD, MSc
- 电话号码:(519) 494-5133
- 邮箱:Mohamed.Ismail@londonhospitals.ca
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
- 观测模型:病例对照
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
VOT assessment of microcirculation
大体时间:day one
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change in reperfusion slope of VOT will be assessed each 30 min during CPB and compared between vasopressin and placebo patients
|
day one
|
合作者和调查者
调查人员
- 首席研究员:MOHAMED ISMAIL, MD,MSc、London HSC
- 研究主任:JOHN MURKIN, MD, FRCPC、London HSC
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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