A Multi-center, Randomized Controlled Trial of Goal-directed Perfusion in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Incidence of postoperative AKI
研究概览
简要总结
Previous studies (1-5) have demonstrated that oxygen delivery (DO2) and carbon dioxide production (VCO2) during cardiopulmonary bypass (CPB) are associated with renal outcome in cardiac surgery. The critical value for DO2 is around 262 - 272 mL/min/m2, and the correspondent critical value of DO2/VCO2 ratio is around 5.0.
Patients with nadir DO2 and DO2/VCO2 ratio below these critical levels have an increased incidence of acute kidney injury (AKI) after cardiac operations.
These observations offer an interpretation for the well-known deleterious effects of excessive hemodilution during CPB, supported by many studies where an association between nadir hematocrit (HCT) on CPB and bad outcomes (especially renal) was found (6-8). It is reasonable to hypothesize that a low oxygen delivery may determine an ischemic damage to the kidney, that due to its peculiar circulation is particularly susceptible to a decrease in the oxygen supply.
However, there is no evidence that a strategy directed towards the specific goal of avoiding critical values of DO2 during CPB may actually decrease the postoperative AKI rate.
The present study is designed to verify the hypothesis that a strategy based on a goal-directed perfusion, aimed to avoid a nadir DO2 below the critical threshold, is effective in limiting the postoperative AKI rate.
详细描述
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Study design Multicenter, international, prospective, randomized and controlled study. Patient population
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Inclusion criteria: Adult (> 18 years) patients undergoing cardiac operations with CPB.
Expected CPB duration > 90 minutes. 2. Exclusion criteria: severe chronic renal failure (dialysis or serum creatinine > 3.0 mg/dL); emergent (must be operated immediately) procedure; moderate-severe anemia (preoperative HCT < 32%); expected nadir CPB temperature < 32 °C. 3. Withdrawal criteria (after randomization): Need for allogeneic blood transfusions before CPB. Need for allogeneic blood to prime the CPB circuit. DHCA or other violations of the entry criteria. CPB duration below 90 minutes will not be withdrawal criterion, but a subroup analysis is anticipated.
Primary outcomes
Incidence of AKI, defined according to the AKIN criteria (9) as:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing cardiac operations with CPB. Expected CPB duration > 90 minutes.
排除标准
- •Exclusion criteria: severe chronic renal failure (dialysis or serum creatinine > 3.0 mg/dL); emergent (must be operated immediately) procedure; moderate-severe anemia (preoperative HCT < 32%); expected nadir CPB temperature < 32 °C.
结局指标
主要结局
Incidence of postoperative AKI
时间窗: 48 postoperative hours
Acute kidney injury defined according to the AKIN criteria (stage 1, stage 2, any AKI, serum creatinine increase)
次要结局
- ICU stay(15 postoperative days)
- Transfusion of red blood cells(15 postoperative days)
- Major morbidity(15 postoperative days)
- Mortality(30 days after surgery)
研究者
Marco Ranucci
Director of Cardiothoracic Anesthesia and ICU Dept
IRCCS Policlinico S. Donato