背景:患有肝硬化和腹水的重症患者发生腹内高压(IAH)的风险很高,这会增加死亡率。临床指南建议将腹内压(IAP)保持在16mmHg以下;尽管如此,超过3/4的肝硬化危重患者在入住ICU的第一周出现IAH.标准护理间歇性大容量穿刺(LVP)缓解腹壁张力,减少IAP,优化腹部灌注压,并与肾脏和肺功能障碍的短期改善有关。然而,没有证据表明不同穿刺策略在预防和治疗肝硬化危重患者IAH中的优越性.该试验旨在比较连续被动穿刺与LVP在肝硬化和腹水患者IAH的预防和治疗中的结果。
方法:研究者发起,开放标签,随机对照试验,设置在专门治疗肝病的一般ICU中,于2022年8月启动,预计持续时间为36个月。将随机分配70例肝硬化和腹水患者,以1:1的比例,接受两种治疗性穿刺方法之一。一种分层随机化方法,以最大肌酐和IAP值为地层,将在试验组分配前均匀化患者基线特征,入院后24小时内。在对照组中,LVP将根据临床实践间歇进行,最大持续时间为8小时,while,在干预组中,持续的被动穿刺将排出腹水长达7天。主要终点是血清肌酐浓度,次要终点包括IAP,测量肌酐清除率,每日尿量,3期急性肾损伤和多器官功能障碍在入组后第7天评估,以及28天死亡率和无肾脏替代治疗天数,和停留时间。在肾脏替代疗法的情况下,将使用预先指定的值,预先ICU出院,肝移植和死亡。安全性分析将包括与穿刺相关的并发症发生率和危害。数据将通过意向治疗方法进行分析。
结论:这是第一个比较不同治疗性穿刺策略对肝硬化和腹水危重患者IAH预防和治疗器官功能障碍和预后的影响的试验。
背景:ClinicalTrials.govNCT04322201。2019年12月20日注册。
BACKGROUND: Critically ill patients with cirrhosis and ascites are at high risk for intra-abdominal hypertension (IAH) which increases mortality. Clinical guidelines recommend maintaining intra-abdominal pressure (IAP) below 16 mmHg; nonetheless, more than three quarters of critically ill patients with cirrhosis develop IAH during their first week of ICU stay. Standard-of-care intermittent large-volume paracentesis (LVP) relieves abdominal wall tension, reduces IAP, optimizes abdominal perfusion pressure, and is associated with short-term improvement in renal and pulmonary dysfunction. However, there is no evidence of the superiority of different paracentesis strategies in the prevention and treatment of IAH in critically ill patients with cirrhosis. This trial aims to compare the outcomes of continuous passive paracentesis versus LVP in the prevention and treatment of IAH in patients with cirrhosis and ascites.
METHODS: An investigator-initiated, open label, randomized controlled trial, set in a general ICU specialized in liver disease, was initiated in August 2022, with an expected duration of 36 months. Seventy patients with cirrhosis and ascites will be randomly assigned, in a 1:1 ratio, to receive one of two methods of therapeutic paracentesis. A stratified randomization method, with maximum creatinine and IAP values as strata, will homogenize patient baseline characteristics before trial group allocation, within 24 h of admission. In the control group, LVP will be performed intermittently according to clinical practice, with a maximum duration of 8 h, while, in the intervention group, continuous passive paracentesis will drain ascitic fluid for up to 7 days. The primary endpoint is serum creatinine concentration, and secondary endpoints include IAP, measured creatinine clearance, daily urine output, stage 3 acute kidney injury and multiorgan dysfunction assessed at day 7 after enrollment, as well as 28-day mortality rate and renal replacement therapy-free days, and length-of-stay. Prespecified values will be used in case of renal replacement therapy or, beforehand ICU discharge, liver transplant and death. Safety analysis will include paracentesis-related complication rate and harm. Data will be analyzed with an intention-to-treat approach.
CONCLUSIONS: This is the first trial to compare the impact of different therapeutic paracentesis strategies on organ dysfunction and outcomes in the prevention and treatment of IAH in critically ill patients with cirrhosis and ascites.
BACKGROUND: ClinicalTrials.gov NCT04322201 . Registered on 20 December 2019.