静脉注射硫酸镁预防危重症患者万古霉素联合哌拉西林他唑巴坦引起的急性肾损伤：一项开放标签、安慰剂对照、随机临床试验。
Intravenous magnesium sulfate for prevention of vancomycin plus piperacillin-tazobactam induced acute kidney injury in critically ill patients: An open-label, placebo-controlled, randomized clinical trial.
机构信息
Department of Pharmacotherapy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Department of Intensive Care Unit, Faculty of Medicine, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.
出版信息
Daru. 2021 Dec;29(2):341-351. doi: 10.1007/s40199-021-00411-x. Epub 2021 Aug 31.
BACKGROUND
Recent studies have shown an increased risk of acute kidney injury (AKI) induced by vancomycin + piperacillin-tazobactam (VPT) combination. In this study, the efficacy of intravenous magnesium sulfate in prevention of VPT induced AKI in critically ill patients admitted to the ICU has been evaluated.
METHODS
In an open-label, placebo-controlled, randomized clinical trial, 72 adults (≥ 18 years old) who had indications to receive VPT as empiric therapy were assigned to the magnesium or control group in 1:1 ratio. Concomitant with VPT, intravenous infusion of magnesium sulfate was started for patients in the magnesium group. The target serum level of magnesium was defined 3 mg/dl. Patients in the control group received normal saline as placebo. The target serum level of magnesium was defined 1.9 mg/dl in this group. The study's primary outcome was incidence of AKI during and up to 48 h after the treatment course. Escalation and de-escalation of VPT regimen, duration of hospitalization, length of ICU stay and 28-day mortality were secondary outcomes.
RESULTS
Thirty patients in each group completed the examination. Five patients in the magnesium group and 11 patients in the control group experienced AKI (p = 0.072). De-escalation of VPT regimen was done approximately in 60% of patients. Duration of hospitalization and length of ICU stay were not statistically different between the groups. Finally, 28-day mortality was 23.33% in each group. Although the incidence of AKI was not statistically different between the groups in unadjusted logistic regression model, it became significant after adjusting for confounding factors [unadjusted model (OR = 0.34; 95% CI: 0.10-1.16, p = 0.084), adjusted model: (OR = 0.26; 95% CI: 0.07-0.96, p = 0.04)].
CONCLUSIONS
Administration of magnesium sulfate with the target serum levels around 3 mg/dL reduced the incidence of AKI in critically ill patients who were receiving VPT as empric therapy.
背景
最近的研究表明，万古霉素+哌拉西林他唑巴坦（VPT）联合用药会增加急性肾损伤（AKI）的风险。在这项研究中，评估了静脉注射硫酸镁对 ICU 收治的危重症患者预防 VPT 诱导 AKI 的疗效。
方法
这是一项开放标签、安慰剂对照、随机临床试验，将 72 名（≥18 岁）有接受 VPT 经验性治疗指征的成年人按 1:1 的比例分为硫酸镁组或对照组。在给予 VPT 的同时，硫酸镁静脉滴注开始用于硫酸镁组患者。将血清镁的目标水平定义为 3mg/dL。对照组患者给予生理盐水作为安慰剂。该组的目标血清镁水平定义为 1.9mg/dL。研究的主要结局是治疗过程中和治疗后 48 小时内 AKI 的发生率。VPT 方案的升级和降级、住院时间、ICU 住院时间和 28 天死亡率为次要结局。
结果
每组各有 30 名患者完成了检查。硫酸镁组有 5 名患者和对照组有 11 名患者发生 AKI（p=0.072）。大约 60%的患者下调了 VPT 方案。两组患者的住院时间和 ICU 住院时间无统计学差异。最终，每组 28 天死亡率为 23.33%。虽然在未调整的逻辑回归模型中，两组间 AKI 的发生率无统计学差异，但在调整混杂因素后变得显著[未调整模型（OR=0.34；95%CI：0.10-1.16，p=0.084）；调整模型：（OR=0.26；95%CI：0.07-0.96，p=0.04）]。
结论
在接受 VPT 经验性治疗的危重症患者中，将血清镁水平维持在 3mg/dL 左右，可降低 AKI 的发生率。
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