SODIUM ACETATE

乙酸钠

基本信息

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
项目类别：
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

项目摘要

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.

该子项目是利用该技术的众多研究子项目之一资源由 NIH/NCRR 资助的中心拨款提供。子项目和研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金，因此可以在其他 CRISP 条目中表示。列出的机构是中心，不一定是研究者的机构。简介：早产儿代谢性酸中毒的发生率较高。为了抵消这种酸中毒，全肠外营养 (TPN) 溶液中通常含有醋酸钠和/或醋酸钾。在出生后的最初 24 至 48 小时内，不能将醋酸钠或醋酸钾添加到早产儿的 TPN 液体中。因此，在出生后的最初几天，出现严重代谢性酸中毒的婴儿通常需要静脉注射碳酸氢钠（或容量扩张）来对抗酸中毒。这两种治疗都与发病率和死亡率增加有关。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连续输注醋酸钠，一直持续到将醋酸钠添加到 TPN 中。尽管这种做法被广泛使用，但尚未报道研究其功效的随机对照试验。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连续输注醋酸钠以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 周以下的早产儿中含有乙酸钠的动脉导管液和含有氯化钠的动脉导管液。方法：将入住卡皮奥拉尼 (NSCU) 妇女儿童医疗中心 (KMCWC) 新生儿特殊护理病房且需要脐带或外周动脉导管的 30 周以下早产新生儿在获得知情同意后依次入组。登记的婴儿将被随机分配到两个研究组之一。治疗组将接受0.45%乙酸钠(0.45%NaAc)作为他/她的动脉导管输注液。对照组将接受0.45%氯化钠（0.45% NS）作为他/她的动脉导管输注液。研究人员和所有护理人员将不知道每个婴儿接受的液体类型。将收集每组所有婴儿出生后 5 天内的数据。主要结果指标包括血清电解质水平（钠、氯和二氧化碳）、动脉血气数据（pH、paCO2 和碱过剩）、使用血浆容量扩张（生理盐水或白蛋白推注）以及碳酸氢钠给药。 A、假设： 1. 与 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 动脉导管液可显着改善酸碱状态。 3. 与 0.45% NS 动脉导管液相比，使用 0.45% NaAc 动脉导管液可防止使用容量扩张。 4. 与 0.45% NS 动脉导管液相比，使用 0.45% NaAc 动脉导管液可防止碳酸氢钠给药。 B. 目标：确定与 0.45% NS 动脉导管液相比，使用 0.45% NaAc 动脉导管液是否会导致血清电解质（钠、氯化物或 CO2）、酸碱状态以及使用扩容和碳酸氢钠给药产生显着差异。