Oczkowski Simon J W, Mazzetti Ian, Meade Maureen O, Hamielec Cindy
Division of Critical Care Medicine, McMaster University, Hamilton, ON, Canada.
Trials. 2014 Jun 12;15:222. doi: 10.1186/1745-6215-15-222.
Fluid retention is a common complication of critical illness. It typically results from large-volume fluid infusions during acute resuscitation and is worsened by hypoalbuminemia. Recognized as edema, fluid retention is important for its association with delayed weaning and increased mortality. The standard treatment is the administration of diuretics, with or without albumin. We hypothesize that intravenous 25% albumin plus furosemide, by comparison with furosemide alone, improves diuresis, oxygenation, and hemodynamic stability in the deresuscitation of critically ill, hypoalbuminemic patients. We propose a pilot study to determine the feasibility of a trial to investigate this hypothesis.
METHODS/DESIGN: FADE is a single-center, parallel, pilot randomized controlled trial. We aim to allocate 50 hemodynamically stable, hypoalbuminemic adult patients receiving diuresis to treatment with either 100 ml of either 25% albumin or normal saline placebo twice daily, for a total of six doses. Diuretics are to be prescribed by the caregiving team at least twice daily, and administered within 2 hours following study treatment. Patients, intensive care unit (ICU) clinicians, data collectors, and outcome adjudicators will be blinded to treatment allocation. Feasibility outcome measures include the proportion of patients receiving albumin within 2 hours of diuretic, the proportion of patients receiving the full six doses of study treatment, the proportion of patients who receive open label 25% albumin, and the rate of recruitment. Physiologic, laboratory, and clinical data are collected until discharge from the ICU or until 30 days.
This is the first randomized trial to assess the use of hyperoncotic albumin in addition to diuretics in a general ICU population. Should this pilot study demonstrate feasibility, the primary outcome measure of the larger clinical trial will be the number of ventilator-free days, with secondary clinical outcome measures of duration of mechanical ventilation, length of ICU stay, episodes of hemodynamic instability and mortality. The addition of 25% albumin to standard diuretic therapy is a promising treatment in the post-resuscitation care of the critically ill patient.
ClinicalTrials.gov NCT02055872; ISRCTN70191881.
液体潴留是危重病的常见并发症。它通常源于急性复苏期间大量的液体输注，并因低白蛋白血症而加重。液体潴留被认为是水肿，因其与脱机延迟和死亡率增加相关而备受关注。标准治疗方法是使用利尿剂，可加用或不加用白蛋白。我们假设，对于危重病、低白蛋白血症患者的复苏后治疗，静脉注射25%白蛋白加呋塞米与单独使用呋塞米相比，能改善利尿、氧合及血流动力学稳定性。我们提议开展一项初步研究，以确定对这一假设进行试验的可行性。
方法/设计：FADE是一项单中心、平行、初步随机对照试验。我们旨在将50名接受利尿治疗的血流动力学稳定的低白蛋白血症成年患者，随机分配接受每日两次、每次100 ml的25%白蛋白或生理盐水安慰剂治疗，共六剂。利尿剂由护理团队至少每日两次开具处方，并在研究治疗后2小时内给药。患者、重症监护病房（ICU）临床医生、数据收集者和结果判定者均对治疗分配不知情。可行性结果指标包括在使用利尿剂后2小时内接受白蛋白治疗的患者比例、接受全部六剂研究治疗的患者比例、接受开放标签25%白蛋白治疗的患者比例以及招募率。收集生理、实验室和临床数据，直至患者从ICU出院或直至30天。
这是第一项评估在普通ICU人群中除利尿剂外使用高渗白蛋白的随机试验。如果这项初步研究证明可行，更大规模临床试验的主要结果指标将是无呼吸机天数，次要临床结果指标包括机械通气持续时间、ICU住院时间、血流动力学不稳定发作次数和死亡率。在标准利尿剂治疗中加用25%白蛋白对危重病患者复苏后护理而言是一种有前景的治疗方法。
ClinicalTrials.gov NCT02055872；ISRCTN70191881。
