背景:血液磷酸盐(Pi)水平的畸变,无论是表现为低磷酸盐血症还是高磷酸盐血症,入住重症监护病房(ICU)的患者似乎与临床并发症和不良结局相关.然而,在ICU患者中,Pi障碍的患病率以及与导致死亡的后续因素和器官功能衰竭的相关性描述不甚清楚.尽管努力从系统评价和荟萃分析中了解低Pi水平的病因和治疗方法,文献缺乏治疗低磷酸盐血症的全面指导.高磷酸盐血症,另一方面,似乎与危重患者死亡率较高有关,然而它在ICU患者中的患病率,特别是在磷酸盐补充之后,仍然未知。本研究旨在调查ICU入院时Pi异常的患病率及其在ICU入住第一周的发生率。与Pi改变相关的因素,以及磷酸盐补充对Pi水平正常化的影响,及其与临床结果的关联。
方法:这个多中心,prospective,作为GUTPHOS研究的B部分,非干预性队列研究将包括至少1000名连续的ICU成年患者(≥18岁).如果预计在2024年1月至2024年6月的八周内最低限度地纳入50名符合条件的患者,并且预计在ICU住院的前七天内每天进行磷酸盐测量,则这些地点符合资格。在招募期间,所有连续的成年患者都进入了参与的ICU,持续八周,或多达120名患者,如果入学人数较早达到该限制,将包括在内。研究参数包括研究地点特征,患者人口统计学,每日评估Pi水平,Pi相关治疗,喂养细节,肾脏替代治疗细节,再喂养相关低磷酸盐血症的发生率和给药(ICU住院的前7个日历日)。将有最长90天的随访期,以记录28天和90天全因死亡率作为主要结果。除受试者工作特征曲线外,多元逻辑回归还将用于评估与死亡率的独立关联,以确定与死亡率和过度校正相关的临界点Pi值。将进行线性混合模型以评估Pi治疗效果。亚组分析将根据ICU入院期间观察到的Pi异常进行,归类为正常-,假设-,hyper-,或混合,连同其严重程度(轻度,中度,或严重)。
结论:GUTPHOS研究将是第一个多中心,前瞻性观察性队列研究,以调查患病率,管理实践,以及ICU入住第一周与Pi异常相关的结果。其结果可能会弥合目前在补充方案中的证据空白,同时为随后的随机对照试验奠定基础。
BACKGROUND: Aberrations in blood phosphate (Pi) levels, whether presenting as hypo- or hyperphosphatemia, appear to be associated with clinical complications and adverse outcomes in patients admitted to an intensive care unit (ICU). However, the prevalence of Pi disorders and the association with subsequent factors and organ failures leading to death in ICU patients are poorly described. Despite endeavors to understand the etiology and treatment of low Pi levels from systematic reviews and meta-analyses, the literature lacks comprehensive guidance for managing
hypophosphatemia. Hyperphosphatemia, on the other hand, appears to be associated with higher mortality among critically ill patients, yet its prevalence among ICU patients, particularly following phosphate repletion, remains unknown. The present study aims to investigate the prevalence of Pi abnormalities upon ICU admission and their incidence during the first week of ICU stay, the factors associated with Pi alterations, and the effect of phosphate repletion on the normalization of Pi levels, and its associations with clinical outcomes.
METHODS: This multicentre, prospective, non-interventional cohort study will include at least 1000 consecutive adult ICU patients (≥18 years) as part B of the GUTPHOS study. Sites are eligible if an anticipated minimal inclusion of 50 eligible patients during eight weeks from January 2024 until June 2024 and daily phosphate measurements during the first seven days of ICU stay are expected. All consecutive adult patients admitted to a participating ICU during the recruitment period, lasting up to eight weeks, or up to 120 patients if enrollment reaches that limit earlier, will be included. Study parameters include study site characteristics, patient demographics, daily assessment of Pi levels, Pi-related treatment, feeding details, renal replacement therapy details, the incidence of refeeding-associated
hypophosphatemia and administered medication (during the first seven calendar days of ICU stay). There will be a follow-up period of a maximum of 90 days to document 28- and 90-day all-cause mortality as the primary outcome. Multiple logistic regression will be used to assess independent associations with mortality in addition to Receiver Operating Characteristics curves to identify cut-off Pi values associated with mortality and overcorrection. Linear mixed models will be conducted to assess Pi treatment effects. Subgroup analyses will be performed based on Pi abnormalities observed during ICU admission, categorized as normo-, hypo-, hyper-, or mixed, along with its severity (mild, moderate, or severe).
CONCLUSIONS: The GUTPHOS study will be the first multicentre, prospective observational cohort study to investigate the prevalence, management practices, and consequent outcomes associated with Pi abnormalities during the first week of ICU admission. Its results may bridge the current evidence gap in repletion protocols while establishing the groundwork for a subsequent randomized controlled trial.
BACKGROUND: NCT05909722.