SODIUM ACETATE

乙酸钠

• 批准号: 7960446
• 负责人: CHARLES RICHARD NEAL
• 金额: $ 1.42万
• 依托单位: UNIVERSITY OF HAWAII AT MANOA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7960446
• 关键词: Acetates; Acidosis; Acids; Affect; Albumins; Blinded; Blood Plasma Volume; Blood gas; Bolus Infusion; Carbon Dioxide; Caregivers; Caring; Catheters; Child; Chloride Ion; Chlorides; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Control Groups; Data; Double-Blind Method; Effectiveness; Electrolytes; Enrollment; Funding; Grant; Hour; Incidence; Infant; Informed Consent; Infusion procedures; Institution; Intravenous; Life; Liquid substance; Medical center; Metabolic acidosis; Methods; Morbidity - disease rate; Newborn Infant; Normal saline; Outcome Measure; Peripheral; Potassium; Pregnancy; Premature Infant; Randomized; Randomized Controlled Trials; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Resources; Safety; Serum; Sodium; Sodium Acetate; Sodium Bicarbonate; Sodium Chloride; Solutions; Source; Total Parenteral Nutrition; United States National Institutes of Health; Woman; base; control trial; improved; mortality; prevent; primary outcome; prospective; trial comparing

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Introduction: Preterm infants have a high incidence of metabolic acidosis. To counteract this acidosis sodium and/or potassium acetate is routinely included in total parenteral nutrition (TPN) solutions. During the first 24 to 48 hours of life neither sodium nor potassium acetate can be added to TPN fluids in premature infants. As a result, during the first few days of life, infants that develop significant metabolic acidosis are often treated with intravenous sodium bicarbonate (or volume expansion) to counteract acidosis. Both of these treatments are associated with increased morbidity and mortality. A common alternative practice is the use of a continuous sodium acetate infusion via the umbilical or peripheral arterial catheter starting on the first day of life and continuing until acetate is added to the TPN. Although this practice is widely used, no randomized control trials to investigate its efficacy have been reported. The proposed study is intended to evaluate the effectiveness and safety of a continuous sodium acetate infusion through an umbilical or peripheral arterial catheter in the first days of life to counteract early metabolic acidosis in premature infants. Research Design: This will be a prospective, randomized, double-blinded control trial, comparing arterial catheter fluids containing sodium acetate to arterial catheter fluids containing sodium chloride in premature infants less than 30 weeks gestation. Methods: Preterm neonates under 30 weeks gestation admitted to the Newborn Special Care Unit at Kapiolani (NSCU) Medical Center for Women and Children (KMCWC) and requiring either an umbilical or peripheral arterial catheter will be sequentially enrolled after obtaining informed consent. Enrolled infants will be randomly assigned to one of two study groups. The treatment group will receive 0.45% sodium acetate (0.45% NaAc) as his/her arterial catheter infusion fluid. The control group will receive 0.45% sodium chloride (0.45% NS) as his/her arterial catheter infusion fluid. Investigators and all care givers will be blinded to the type of fluid received by each infant. Data will be collected on all infants in each group during the first 5 days of life. Primary outcome measures will include serum electrolyte levels (sodium, chloride and CO2), arterial blood gas data (pH, paCO2, and base excess), use of plasma volume expansion (normal saline or albumin boluses), and sodium bicarbonate administration. A. Hypotheses: 1. The use of 0.45% NaAc arterial catheter fluids does not adversely affect serum sodium or chloride levels when compared to 0.45% NS arterial catheter fluids. 2. The use of 0.45% NaAc arterial catheter fluids significantly improves acid base status when compared to 0.45% NS arterial catheter fluids. 3. The use of 0.45% NaAc arterial catheter fluid prevents the use of volume expansion when compared to 0.45% NS arterial catheter fluids. 4. The use of 0.45% NaAc arterial catheter fluid prevents sodium bicarbonate administration when compared to 0.45% NS arterial catheter fluids. B. Objective: Determine if the use of 0.45% NaAc arterial catheter fluids results in a significant difference in serum electrolytes (sodium, chloride or CO2), acid base status and the use of volume expansion and sodium bicarbonate administration when compared to 0.45% NS arterial catheter fluids.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 前言：早产儿是代谢性酸中毒的高发人群。为了消除这种酸中毒，通常在全肠外营养(TPN)溶液中加入醋酸钠和/或醋酸钾。在生命的最初24至48小时内，不能向早产儿的TPN液中添加醋酸钠或醋酸钾。因此，在生命的最初几天，出现严重代谢性酸中毒的婴儿通常要静脉注射碳酸氢钠(或容量扩张)来抵消酸中毒。这两种治疗方法都会增加发病率和死亡率。一种常见的替代做法是从出生第一天开始通过脐带或外周动脉导管持续输注醋酸钠，一直持续到醋酸盐加入TPN。虽然这种做法被广泛应用，但尚未有研究其疗效的随机对照试验的报道。这项拟议的研究旨在评估在生命的最初几天通过脐带或外周动脉导管持续输注醋酸钠来对抗早产儿早期代谢性酸中毒的有效性和安全性。 研究设计：这将是一项前瞻性、随机、双盲对照试验，比较妊娠30周以下早产儿动脉导管液中含有醋酸钠和含有氯化钠的情况。 方法：在Kapiolani(NSCU)妇女儿童医学中心(KMCWC)新生儿特别护理病房(KMCWC)住院的30周以下早产儿，在获得知情同意后，将按顺序登记，需要脐带或外周动脉导管。登记的婴儿将被随机分配到两个研究组中的一个。治疗组应用0.45%醋酸钠(0.45%NaAc)作为动脉导管输液。对照组给予0.45%氯化钠(0.45%生理盐水)动脉导管输液。调查人员和所有护理人员将被蒙在鼓里，不知道每个婴儿接受的液体类型。将收集每组婴儿在出生后头5天的数据。主要观察指标将包括血清电解质水平(钠、氯和二氧化碳)、动脉血气数据(pH、PaCO2和碱过量)、血浆容量扩张的使用(生理盐水或白蛋白丸剂)和碳酸氢钠的注射。 A.假设： 1.与使用0.45%NS动脉导管液相比，使用0.45%NaAc动脉导管液不会对血清钠或氯水平产生不利影响。 2.与0.45%NS动脉导管液相比，使用0.45%NaAc动脉导管液能显著改善酸碱状况。 3.与使用0.45%NS动脉导管液相比，使用0.45%NaAc动脉导管液可防止容量扩张。 4.与使用0.45%生理盐水动脉导管液体相比，使用0.45%NaAc动脉导管液体可防止碳酸氢钠的使用。 B.目标： 确定使用0.45%NaAc动脉导管液与使用0.45%NS动脉导管液相比，是否会导致血清电解质(钠、氯或二氧化碳)、酸碱状况以及使用扩容和注射碳酸氢钠的情况有显著差异。