Effect of Albumin Versus Routine Care on Hemodynamic Response and Stability in Patients With Preeclampsia Guided by a Non-invasive Hemodynamic Monitoring System During Cesarean Delivery With Spinal Anesthesia - A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Number of participants with fluid responsiveness
研究概览
简要总结
The purpose of this study is to compare the effect of albumin versus routine care on hemodynamic response and stability in pre-eclamptic patients during cesarean delivery. The hypothesis is that volume replacement with albumin guided by stroke volume variation (SVV) using a ClearSight-Acumen (CS-A) monitor, before cesarean delivery (CD), improves hemodynamic stability in preeclamptic patients with severe features compared to routine care, under neuraxial anesthesia.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age greater or equal to 24 weeks
- •Diagnosis of preeclampsia with severe features [Pre-eclampsia is defined as high blood pressure after 20 weeks with or without proteinuria. Pre-eclampsia with severe features is defined as the presence of preeclampsia with any of the following features: severe hypertension (blood pressure ≥160/110 mmHg on two separate occasions); thrombocytopenia (platelet count <100,000 per microliter); impaired liver function (elevated liver transaminases to twice the normal concentration or severe persistent right upper quadrant or epigastric pain not responsive to medications); progressive renal insufficiency with a serum creatinine level of >1.1 mg/dl or doubling of the serum creatinine level in the absence of other renal disease; pulmonary edema or unexplained new-onset cerebral symptoms (headache) unresponsive to medications or visual disturbances.]
- •Scheduled Cesarean Delivery
- •Unscheduled Cesarean Delivery with the goal to proceed to the operating room within no less than 30 minutes due to concern for maternal or fetal status that is not immediately life threatening.
- •Requiring Neuraxial Anesthesia (spinal or CSE)
排除标准
- •Patient declines to participate in the study
- •Contraindications to the use of neuraxial anesthesia (coagulopathy, infection at the insertion site, intracranial mass etc.)
- •Unscheduled Cesarean Delivery with the goal to proceed to the operating room immediately for delivery of the baby due to imminent/unavoidable threat to the life of the mother or fetus.
- •The use of or conversion to General Anesthesia
- •Non-reassuring fetal status including the presence of cardiac or multi-system anomalies, category III tracing etc.
- •Significant maternal cardiopulmonary disease including pulmonary hypertension, ischemic heart disease with systolic dysfunction, pulmonary edema etc.
- •Significant intraoperative events (such as hemorrhage) requiring administration of multiple blood products and ICU admission.
研究组 & 干预措施
Fluid restriction using crystalloid
Fluid restriction will be achieved with the crystalloid lactated ringer's injection administered at at a keep-the-vein-open (KVO) rate of 75 milliliters per hour (mL/hr).
干预措施: Lactated Ringer's Injection (crystalloid) (Drug)
Fluid replacement using colloid as guided by stroke volume variation (SVV)
Fluid replacement will be achieved with the colloid 5% albumin infusion. Use of colloid will be guided by stroke volume variation (SVV) as assessed by the Edwards HemoSphere monitor with ClearSight-Acumen finger cuff device.
干预措施: Human Albumin (colloid) (Drug)
Fluid replacement using colloid as guided by stroke volume variation (SVV)
Fluid replacement will be achieved with the colloid 5% albumin infusion. Use of colloid will be guided by stroke volume variation (SVV) as assessed by the Edwards HemoSphere monitor with ClearSight-Acumen finger cuff device.
干预措施: Edwards HemoSphere monitor with ClearSight-Acumen finger cuff (Device)
结局指标
主要结局
Number of participants with fluid responsiveness
时间窗: from baseline to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU)
"Fluid responsiveness" (in other words, a "positive response") is defined as a volume-induced correction to stroke volume variation (SVV) values \< 13%. SVV measurements will be made using the Edwards HemoSphere monitor with ClearSight-Acumen finger cuff.
次要结局
- Maternal blood pressure (systolic)(baseline, after infusion of study intervention, at completion of placement of the spinal/CSE anesthesia, at completion of delivery of the baby, at end of procedure when leave operating room, thirty minutes after arrival to PACU)
- Maternal blood pressure (diastolic)(baseline, after infusion of study intervention, at completion of placement of the spinal/CSE anesthesia, at completion of delivery of the baby, at end of procedure when leave operating room, thirty minutes after arrival to PACU)
- Total amount in milligrams of rescue vasopressor drug given(from start of operation to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU))
- Number of participants with fluid responsiveness stability(from baseline to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU))
- Number of adverse events(from start of operation to discharge from the Post Anesthesia Care Unit (PACU))
研究者
Onyi C Onuoha
Associate Professor
The University of Texas Health Science Center, Houston