Using Polysulfone Membranes on Continuous Ultrafiltration With Volume Replacement in Patients Undergoing Cardiac
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Plasma Lactate Level
研究概览
简要总结
This study aims to analyze the impact of using polysulfone membranes on continuous ultrafiltration with volume replacement in patients undergoing cardiac surgery. In this type of surgery, techniques such as conventional ultrafiltration (CUF) and modified ultrafiltration (MUF) are known for controlling the patient's fluid balance during the procedure. However, there is no scientific evidence on the benefits of continuous haemofiltration with volume replacement and its effect on lactatemia. Method and design: A single center randomized controlled trial, parallel treatment design with patient-blinded to compare outcomes in terms of the lactate clearance rates (quantity/unit of time) of the assigned therapy groups. Participants will be randomly assigned to receive the type of surgery, in order to ensure an unbiased assessment of treatments, randomisation will be performed in eight blocks of five patients. The study groups will be equivalent in all aspects except the procedures they undergo. Participants will be assigned to the first control group without haemofiltration (CG or 1) or one group with haemofiltration using a Polysulfone filter (PG or 2). Data will be collected by a blinded evaluator.
详细描述
To determine whether continuous ultrafiltration with volume replacement using a polysulfone membrane during Cardiopulmonary Bypass (CPB) in patients undergoing cardiac surgery decreases intraoperative lactatemia.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who signed informed consent
- •Patients not undergoing emergency surgery.
- •Surgical procedures performed under normothermic conditions.
- •Patients with a minimum time of 40 minutes before decannulation (after the end of myocardial reperfusion, unclamping of the aorta and the end of CPB).
排除标准
- •Emergency medical condition in which it is not possible to collect study data.
- •Heart condition requiring the use of hypothermia or hyperthermia during CPB.
- •Patients without a minimum time of 40 minutes before decannulation (after the end of myocardial reperfusion, unclamping of the aorta and the end of CPB).
- •Patients who cannot manage their fluid balance on their own through diuresis prior to CPB.
- •Patients who are unable to manage excess volume during the surgical procedure by means of spontaneous or forced diuresis with diuretics (positive cumulative balance despite intravenous bolus of diuretics after 75% of the anticipated duration of CPB according to the course of the surgery).
研究组 & 干预措施
Polysulfone Filter Group
The purpose of the research is to determine whether, by controlling the patient's hemodilution level and, therefore, the acute anaemia caused by the Cardiopulmonary Bypass (CPB) priming fluid, continuous conventional ultrafiltration (CUF) can decrease serum lactate levels during normothermic CPB by increasing the haematocrit and, consequently, the supply of oxygen to the tissues, and whether the haemofiltration membrane can remove lactate molecules in situations of hyperlactataemia in CPB.
干预措施: Polysulfone Filter (Procedure)
Control Group
The purpose of the research is to determine serum lactate levels during normothermic cardiopulmonary bypass procedure (CPB) without continuous hemofiltration of the patient during the CPB.
干预措施: Procedure/ Surgery: without Polysulfone Filter (Procedure)
结局指标
主要结局
Plasma Lactate Level
时间窗: Baseline
The lactate level will be measured before Cardiopulmonary Bypass (CPB) in all patients
次要结局
- Plasma Lactate Level in the effluent(1 minute after the Cardiopulmonary Bypass (CPB))
- Maximum Plasma Lactate Level(Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB))
- Plasma Lactate Level(1 minute after the Cardiopulmonary Bypass (CPB))
- Plasma Lactate Level in intensive care unit (ICU)(24 hours after the Cardiopulmonary Bypass (CPB))
- Serum potassium Level(Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB))
- Hematocrit(Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB))
- Evaluation criteria of mortality and risk profiles of population(10 minutes before the Cardiopulmonary Bypass (CPB))
研究者
Carlos Garcia Camacho
MSc
University of Cadiz