a Comparison Between the Effects of Crystalloids and Colloids on Lung Ultrasound Score in Preeclamptic Patients Undergoing Spinal Anesthesia for Caesarean Section: a Randomized Double Blinded Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- changes in Lung ultrasound score
研究概览
简要总结
This study is designed to compare the effect of crystalloids and colloids on lung ultrasound score in preeclapmtic pregnant cases undergoing spinal anesthesia for caesarean section
Objectives:
To identify ideal fluid in order to maintain proper intravascular volume in preeclamptic patients that allows organ perfusion without causing lung congestion or pulmonary edema
Hypothesis:
the investigators hypothesize that colloids are better than crystalloids in maintaining good intravascular volume without affecting lung ultrasound score.
详细描述
Hypertensive disorders are the most common complications of pregnancy. They occur in 6-8% of pregnancies and account for approximately 15% of maternal deaths in the United States Pre-eclampsia is a pregnancy-specific syndrome of unknown etiology that is defined as systolic blood pressure (SBP) > 140 mmHg and/or diastolic blood pressure (DBP) > 90 mmHg presenting after 20 weeks of gestation with significant proteinuria (1) Because patients with pre-eclampsia may have significant intravascular volume deficit and reduced uteroplacental perfusion, it is prudent to administer fluids before any anesthetic interventions. (2) however it may increase their risk of developing pulmonary oedema (3) Colloids and crystalloids are two types of fluids that are used for fluid replacement, as volume expanders. Crystalloids are low-cost salt solutions (e.g. saline) with small molecules, which can move around easily when injected into the body. Colloids can be man-made (e.g. starches, dextrans, or gelatins), or naturally occurring (e.g. albumin or fresh frozen plasma (FFP)), and have bigger molecules, so stay in the blood for longer before passing to other parts of the body. (4) Women with pre-eclampsia lose protein through renal excretion and may also extravasate protein into the interstitial tissues, oncotic pressure falls because of this and the tendency to lose fluid from the intravascular space is partially determined by this mechanism. Filling the vascular space with fluid will lead to increasing peripheral oedema. Colloids will remain in the vascular compartment for longer periods than crystalloids although the loss of colloid into the interstitial tissues will also contribute to the development of oedema. Changes in capillary permeability will have an independent influence. (5) Ultrasound is now widely used in many medical specialties, being safe tool for both the parturient and the baby, ultrasound is basically used by the obstetricians in pregnant females for diagnosis of fetal presentation, placental position, fetal organs, amount of liquor and in some interventions amniocentesis. In the last 15 years, a new imaging application of sonography has emerged in the clinical arena: lung ultrasound (LUS), it can give valuable data in diagnosing and management of pneumothorax, pleural effusion, lung consolidation and pulmonary congestion. (6) The electrical cardiometry which can be used to measure and calculate hemodynamic parameters such as cardiac output, stroke volume, systemic vascular resistance, ICON (index of contractility), and thoracic fluid content. (7) In general, there is no epidemiological evidence to support the choice of colloidal solutions over crystalloids and it is not clear that colloidal solutions would be more effective and less likely to cause harm than crystalloids in preeclamptic patients. A meta-analysis was done to investigate crystalloid versus colloid resuscitation in critically ill patients however pregnant women and neonates were excluded. (8) Consequently, there is inadequate evidence supporting one view or another in the management of pre-eclampsia.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant cases with preeclampsia: gestational age >32 weeks
- •Singleton pregnancy
- •Age above 18 years
排除标准
- •Pregnant cases with preeclampsia: gestational age >32 weeks
- •Singleton pregnancy
- •Age above 18 years
研究组 & 干预措施
Group (R)
Group (R): will receive ringer acetate 500ml over 30 minutes
干预措施: saline solution (Drug)
结局指标
主要结局
changes in Lung ultrasound score
时间窗: changes in lung ulrasound is measured by comparing the alvelo interstitial score at baseline (before ) receiving spinal anaesthesia then after 30 minutes
Alveolo-interstitial syndrome is assessed by the measurement of multiple B-lines
次要结局
未报告次要终点
研究者
Karim mohamed abou elella
assisstant lecturer
Kasr El Aini Hospital
