Ultrasound Assessment of Inferior Vena Cava Collapsibility Index (IVCCI) to Guide Pre-operative Fluid Management in Critically Ill Pre-eclamptic Patients in Comparison with the Standard Fluid Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- post-spinal hypotension
研究概览
简要总结
The routine assessment of fluid status depends on clinical evaluation and invasive monitoring. The clinical assessment lacks objectivity and the invasive monitoring carries risks. Point of care ultrasound (POCUS) parameters can be useful as early markers of fluid status and were used in safe fluid assessment in term pregnancy and preeclampsia.
详细描述
Fluid therapy in preeclamptic patients presents a challenge. volume expansion may precipitate pulmonary edema while fluid restriction may worsen renal function and may aggravate post-spinal hypotension during cesarean section.
Pre-eclampsia predisposes to maternal mortality. It presents a serious hypertensive disorder during pregnancy which may progress rapidly to serious complications, including the death of both mother and fetus The optimal fluid management strategy constitutes a cornerstone in the management. The Royal College of Obstetricians and Gynecologists (RCOG) guidelines for severe pre-eclampsia recommend restrictive fluid therapy, in keeping with the absence of evidence favoring volume expansion. Restrictive management is advocated by The Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) with additional fluid administration only recommended before intravenous hydralazine, regional anesthesia, immediate delivery, or in oliguric patients where a volume deficit is suspected.
Overall, limited evidence exists regarding the effectiveness of ultrasound assessment of the IVC collapsibility index to guide pre-operative fluid management in critically ill pre-eclamptic patients. A meta-analysis stated that few research trials are available in the obstetric population. Some studies suggest that it can accurately predict fluid responsiveness, but others argue that it may not be helpful.
Our trial is the first trial that compares the efficacy of IVCCI-guided perioperative fluid therapy against standard fluid therapy guided by clinical parameters in critically ill pre-eclamptic patients.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
- The care provider intraoperative; both the anesthesiologist and the obstetrician will be blinded regarding the intervention.
- The anesthetic residents who will assess the outcome of hypotension are blind regarding the group allocation
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Critically ill pre-eclamptic patients for cesarean section
排除标准
- •Patient refusal
- •severe cardiovascular disease ( ejection fraction < 40 mmHg ), tricuspid regurge.
- •contraindication for spinal anesthesia.
- •failure to perform spinal anesthesia.
- •severe hepatic.
- •renal dysfunction
结局指标
主要结局
post-spinal hypotension
时间窗: 20 minutes after the spinal anesthesia injection
post-spinal anesthesia and early intraoperative (0-20 min) hypotension (MAP \< 65 mmHg and/or ≥ 20% decrease from baseline. Measured by the occurrence or not of hypotension. The aggregation method will be according to the distribution of data if normal mean and SD will be used.
次要结局
- occurrence of complication(from spinal anesthesia till the delivery of the fetus, or within 30 minutes postspinal which comes first)
