Pre Bypass Ultrafiltration (PBUF) Improves Intraoperative Glucose, Sodium, Potassium and Lactate Levels in Children Requiring Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Sodium in milliequivalents per liter (mEq/L). Normal range 135 to 148 mEq/L
研究概览
简要总结
Newborn babies and children with congenital heart defects who need heart surgery need to be placed on the heart-lung machine for heart surgery.
In order to use the heart-lung machine, the investigators have to use blood and other fluids to fill the tubing. During the operation, ultrafiltration is carried out as standard of care to remove extra fluid. Modified ultrafiltration is also performed after surgery. In this study, the investigators are looking to use the filter additionally before surgery. Using the pre bypass filtration before the subject is placed on the heart-lung machine will allow the investigators to better normalize electrolytes in the blood/fluid mixture used in the heart lung machine. This technique is called pre-bypass ultrafiltration, or PBUF (pronounced "P" Buff).
The investigators are conducting a study to see if using PBUF to better normalize electrolytes in the blood will make a difference. The investigators have been adding fluids to prime the heart-lung machine in two different ways. The investigators believe both methods are safe and acceptable but hypothesize that there may be subtle differences in electrolytes and fluid status when one technique is used as opposed to the other. The investigators believe that neither technique introduces risk since both are currently used in practice. The standard method adds blood to the heart-lung machine. The alternate method adds blood to the heart-lung machine and then additional fluid is added and removed to more normalize the electrolytes. The investigators plan to randomized subjects undergoing heart surgery to receive the standard priming method versus PBUF to determine if there is any difference in outcomes. Laboratory and clinical data collected as part of clinical care will be used to determine difference sin outcomes. There will be no additional blood taken for this study.
There are no known risks to PBUF. The benefits include helping investigators determine if PBUF does or does not make a difference to how subjects recover after surgery. The investigators believe that providing more normal blood values will either improve the subjects' outcome or have no benefit. The investigators do not anticipate increased risks.
Given COVID -19 restrictions, the study is on hold.
详细描述
Research question: Can PBUF provide more physiologic values for glucose, sodium, potassium and lactate throughout the cardiopulmonary bypass period without an increased incidence of adverse events?
Background: The values for glucose, sodium, potassium and lactate in blood primes for subjects weighing less than 8 kg are known to be non-physiologic. The process of priming the cardiopulmonary bypass circuit is not standardized across institutions and there are several methods used to correct for known prime value issues. The investigators documented the prime values for 20 subjects weighing less than 8 kg and then performed pre-bypass ultrafiltration (PBUF) on the prime for those same circuits to achieve more physiologic prime values. The investigators were cautious not to implement too significant of a change as the investigators assessed the technique and documented that plasma-free hemoglobin importantly did not rise and that measured osmolality was still slightly above the normal range.
Study type: Prospective randomized controlled study.
Hypothesis: The investigators hypothesize that pre cardiopulmonary bypass ultrafiltration (PBUF) can provide more physiologic prime values for glucose, sodium, potassium and lactate. Plasma-free hemoglobin will not increase with the technique. Osmolality will be maintained slightly above the normal range. PBUF will not negatively impact clinical outcome measures and may improve them.
Specific Aim 1 To determine if use of PBUF will result in more physiologic values for glucose, sodium, potassium and lactate during and immediately after cardiopulmonary 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
- None
入排标准
- 年龄范围
- 1 Day 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients < 8 kilograms and < 1 year (to ensure that all patients receive steroids at initiation of CPB) undergoing an index cardiac operation for that hospitalization (using a single PBUF protocol)
排除标准
- •Patients undergoing repeat cardiac surgery within the same admission
- •Patients undergoing transplants as their index surgery
- •Patients undergoing Ventricular assist device implantation as their index surgery
结局指标
主要结局
Sodium in milliequivalents per liter (mEq/L). Normal range 135 to 148 mEq/L
时间窗: 12 hours
Differences in sodium (mEq/L) at the following time points, and also differences in the percentage of values within the normal range for each time point, for PBUF versus standard care. 1. Final prime value (in the PBUF group after completion of PBUF and prior to cardio pulmonary bypass (CPB), in the control group prior to CPB) 2. First measured levels on bypass - typically 10 minutes post initiation of bypass 3. Last value on CPB 4. Last value in OR 5. First arrival to ICU
Lactate in milliequivalents per liter (mEq/L). Normal range 0.5 to 2.2 mEq/L
时间窗: 12 hours
Differences in lactate (mEq/L) at the following time points, and also differences in the percentage of values within the normal range for each time point, for PBUF versus standard care. 1. Final prime value (in the PBUF group after completion of PBUF and prior to cardio pulmonary bypass (CPB), in the control group prior to CPB) 2. First measured levels on bypass - typically 10 minutes post initiation of bypass 3. Last value on CPB 4. Last value in OR 5. First arrival to ICU
Potassium in milliequivalents per liter (mEq/L). Normal range 3.2 to 4.5 mEg/L
时间窗: 12 hours
Differences in potassium (mEq/L) at the following time points, and also differences in the percentage of values within the normal range for each time point, for PBUF versus standard care. 1. Final prime value (in the PBUF group after completion of PBUF and prior to cardio pulmonary bypass (CPB), in the control group prior to CPB) 2. First measured levels on bypass - typically 10 minutes post initiation of bypass 3. Last value on CPB 4. Last value in OR 5. First arrival to ICU
Glucose in milligrams per deciliter (mg/dL). Normal range 61 to 199 mg/dL
时间窗: 12 hours
Differences in glucose (mg/dl) at the following time points, and also differences in the percentage of values within the normal range for each time point, for PBUF versus standard care. 1. Final prime value (in the PBUF group after completion of PBUF and prior to cardio pulmonary bypass (CPB), in the control group prior to CPB) 2. First measured levels on bypass - typically 10 minutes post initiation of bypass 3. Last value on CPB 4. Last value in OR 5. First arrival to ICU
次要结局
- Postoperative Cardiac intensive care unit (CICU) length of stay (LOS) in days,(Through study completion (until hospital discharge), an average of 15 days.)
- Plasma free hemoglobin in milligrams per deciliter (mg/dL). Normal < 5 mg/dL.(12 hours)
- Inotrope use(72 hours)
- Total ventilation duration (days, hours)(Through study completion (until hospital discharge), an average of 15 days.)
- Osmolality in milli osmoles per kilogram (mOsm/Kg). Normal Range 276- 295 mOsm/kg(12 hours)
- Reintubation as a proportion subjects needing reintubation in each group Reintubation(Through study completion (until hospital discharge), an average of 15 days.)
- Body wall edema as measured daily weights in kilograms (Kg)(Through study completion (until hospital discharge) , an average of 15 days.)
- Initial ventilation duration in days and hours(Through study completion (until hospital discharge), an average of 15 days.)
- Postoperative hospital LOS(Through study completion (until hospital discharge), an average of 15 days.)
- Composite of major adverse events (Postoperative extra corporeal membrane oxygenation (ECMO), reoperation for bleeding, reoperation for low cardiac output state, circuit clotting events) and mortality. Yes or No(Through study completion (until hospital discharge), an average of 15 days.)
研究者
Meena Nathan
Staff Surgeon, Department of Cardiac Surgery
Boston Children's Hospital