A Randomized Controlled Trial Comparing Dextran-based Priming (PrimECC), and Standard Crystalloid and Mannitol-based Priming Solution in Adult Cardiac Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in oncotic pressure in plasma
研究概览
简要总结
This study will compare two priming solutions for extracorporeal circulation, one based on Dextran 40, one based on crystalloid and mannitol. Primary endpoint is oncotic pressure during cardiopulmonary bypass. Secondary endpoints included fluid balance and organ functions.
详细描述
This is a prospective, single center, double-blinded, randomized controlled clinical trial. Eighty patients are randomized 1:1 to either cardiopulmonary bypass with the dextran-based solution or standard priming with Ringer-Acetate and Mannitol.
Primary endpoint will be oncotic pressure during cardio pulmonary bypass. Secondary endpoints include perioperative fluid balance, coagulation, platelet function, postoperative bleeding volume, transfusion requirements, renal function, liver function, pulmonary function, inflammatory activation and markers for brain and heart injury.
Blood samples for oncotic pressure measurements will be collected from an arterial line before and during surgery. Organ function will be assessed before surgery and 2 hours cardio pulmonary bypass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 - 75 years
- •Elective cardiac surgery procedure with expected CBP time above 90 minutes
- •Subject provides a legally effective informed consent.
排除标准
- •Known previous cardiac surgery
- •Coagulation disorder
- •Malignancy
- •Kidney failure
- •Liver failure
- •Ongoing septicaemia
- •Ongoing antithrombotic treatment other than acetylsalicylic acid
- •Systemic inflammatory disorders treated with corticosteroids
- •Not able to understand Swedish
研究组 & 干预措施
PrimECC
1250 ml of a priming solution based on the colloid Dextran 40 to use for extracorporeal circulation.
干预措施: A colloid Dextran 40 solution for extracorporeal circulation (Device)
Ringer-Acetate/Mannitol
1250 ml of a priming solution based on the crystalloid Ringer-Acetate (1000ml) and Mannitol (250ml).
干预措施: Ringer-Acetate and Mannitol (Device)
结局指标
主要结局
Change in oncotic pressure in plasma
时间窗: After 1 hour of cardiopulmonary bypass
The oncotic pressure in plasma is measured using an Osmomat 050 and reported in kPa. Points of measurement is before ECC and at 60 minutes into ECC
次要结局
- Change in coagulation (2).(Within 2 hours after cardiopulmonary bypass)
- Change in platelet function(Within 2 hours after cardiopulmonary bypass)
- Amount of transfusions(Within 24 hours after cardiopulmonary bypass)
- Amount of bleeding(Within 24 hours after cardiopulmonary bypass)
- Change in liver function (2)(Within 2 hours after cardiopulmonary bypass)
- Change in pulmonary function(Within 2 hours after cardiopulmonary bypass)
- Change in brain injury marker (4)(Within 2 hours after cardiopulmonary bypass)
- Change in renal function (1)(Within 2 hours after cardiopulmonary bypass)
- Change in inflammatory activation(Within 2 hours after cardiopulmonary bypass)
- Change in fluid balance(Within 24 hours after cardiopulmonary bypass)
- Change in renal function (2)(After 1 hour of cardiopulmonary bypass)
- Change in coagulation (1).(Within 2 hours after cardiopulmonary bypass)
- Change in liver function (1)(Within 2 hours after cardiopulmonary bypass)
- Change in brain injury marker (1)(Within 2 hours after cardiopulmonary bypass)
- Change in ischemic heart injury marker.(Within 24 hours after cardiopulmonary bypass)
- Change in brain injury marker (3)(Within 2 hours after cardiopulmonary bypass)
- Change in brain injury marker (2)(Within 2 hours after cardiopulmonary bypass)
研究者
Anders Jeppssons
MD, PhD, Professor/Senior consultant
Sahlgrenska University Hospital