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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 前言：早产儿代谢性酸中毒的发生率很高。为了对抗这种酸中毒，全胃肠外营养（TPN）溶液中通常包含醋酸钠和/或醋酸钾。在出生后的最初24至48小时内，早产儿的TPN液体中不能添加醋酸钠或醋酸钾。因此，在出生后的最初几天，发生严重代谢性酸中毒的婴儿通常用静脉注射碳酸氢钠（或扩容）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后第一天开始通过脐动脉或外周动脉导管连续输注醋酸钠，并持续至TPN中加入醋酸盐。虽然这种做法被广泛使用，但没有随机对照试验来研究其疗效。拟定研究旨在评价在出生后最初几天通过脐动脉或外周动脉导管持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，在妊娠小于30周的早产儿中比较含醋酸钠的动脉导管液与含氯化钠的动脉导管液。 研究方法：在获得知情同意书后，将依次入组在Kapiolani（NSCU）妇幼医学中心（KMCWC）新生儿特殊监护室住院的妊娠30周以下的早产新生儿，并需要脐动脉或外周动脉导管。入组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%醋酸钠（0.45% NaAc）作为动脉导管输注液。对照组将接受0.45%氯化钠（0.45% NS）作为动脉导管输注液。研究者和所有护理人员将对每名婴儿接受的液体类型不知情。将在出生后的前5天内收集每组中所有婴儿的数据。主要结局指标将包括血清电解质水平（钠、氯和CO2）、动脉血气数据（pH、PaCO 2和碱过剩）、血浆容量扩张的使用（生理盐水或白蛋白推注）和碳酸氢钠给药。 A.假设条件： 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化物水平产生不良影响。 2.与0.45%NS动脉导管液相比，使用0.45%NaAc动脉导管液可显著改善酸碱状态。 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。目的： 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、氯或CO2）、酸碱状态以及容量扩张和碳酸氢钠给药的显著差异。