急性腎障害における腎再置換療法の開始時期

Timing of Initiation of Renal-Replacement Therapy in Acute Kidney Injury.

• Sean M Bagshaw
• Ron Wald
• Neill K J Adhikari
• Rinaldo Bellomo
• Bruno R da Costa
• Didier Dreyfuss
• Bin Du
• Martin P Gallagher
• Stéphane Gaudry
• Eric A Hoste
• François Lamontagne
• Michael Joannidis
• Giovanni Landoni
• Kathleen D Liu
• Daniel F McAuley
• Shay P McGuinness
• Javier A Neyra
• Alistair D Nichol
• Marlies Ostermann
• Paul M Palevsky
• Ville Pettilä
• Jean-Pierre Quenot
• Haibo Qiu
• Bram Rochwerg
• Antoine G Schneider
• Orla M Smith
• Fernando Thomé
• Kevin E Thorpe
• Suvi Vaara
• Matthew Weir
• Amanda Y Wang
• Paul Young
• Alexander Zarbock

抄録

背景:

急性腎障害は重症患者では一般的であり、その多くは腎再置換療法を受けている。しかし、このような治療を開始するための最も効果的なタイミングは不明である。

BACKGROUND: Acute kidney injury is common in critically ill patients, many of whom receive renal-replacement therapy. However, the most effective timing for the initiation of such therapy remains uncertain.

方法:

重症急性腎不全患者を対象とした多国籍無作為化比較試験を実施した。患者は、腎再置換療法の加速戦略（患者が適格基準を満たしてから12時間以内に治療を開始する）と標準戦略（従来の適応があるか、急性腎障害が72時間以上持続しない限り、腎再置換療法は行われない）に無作為に割り付けられた。主要転帰は90日後の原因不明の死亡であった。

METHODS: We conducted a multinational, randomized, controlled trial involving critically ill patients with severe acute kidney injury. Patients were randomly assigned to receive an accelerated strategy of renal-replacement therapy (in which therapy was initiated within 12 hours after the patient had met eligibility criteria) or a standard strategy (in which renal-replacement therapy was discouraged unless conventional indications developed or acute kidney injury persisted for >72 hours). The primary outcome was death from any cause at 90 days.

結果:

無作為化が行われた3019例のうち、変更後のintention-to-treat解析には2927例（97.0％）が含まれた（加速戦略群1465例、標準戦略群1462例）。これらの患者のうち、腎再置換療法が実施されたのは戦略促進群1418例（96.8％）と標準戦略群903例（61.8％）であった。90日目に死亡した患者は、戦略促進群643例（43.9％）、標準戦略群639例（43.7％）であった（相対リスク、1.00；95％信頼区間[CI]、0.93～1.09；P=0.92）。90日後の生存者において、腎再置換療法への継続的な依存が確認されたのは、加速戦略群では814人中85人（10.4％）、標準戦略群では815人中49人（6.0％）であった（相対リスク、1.74；95％信頼区間[CI]、1.24～2.43）。有害事象は、戦略促進群では1503例中346例（23.0％）に、標準戦略群では1489例中245例（16.5％）に発現した（P<0.001）。

RESULTS: Of the 3019 patients who had undergone randomization, 2927 (97.0%) were included in the modified intention-to-treat analysis (1465 in the accelerated-strategy group and 1462 in the standard-strategy group). Of these patients, renal-replacement therapy was performed in 1418 (96.8%) in the accelerated-strategy group and in 903 (61.8%) in the standard-strategy group. At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92). Among survivors at 90 days, continued dependence on renal-replacement therapy was confirmed in 85 of 814 patients (10.4%) in the accelerated-strategy group and in 49 of 815 patients (6.0%) in the standard-strategy group (relative risk, 1.74; 95% CI, 1.24 to 2.43). Adverse events occurred in 346 of 1503 patients (23.0%) in the accelerated-strategy group and in 245 of 1489 patients (16.5%) in the standard-strategy group (P<0.001).

結論:

急性腎不全の重症患者において、腎再置換療法の早期化は標準療法に比べて90日後の死亡リスクの低下とは関連していなかった。カナダ保健研究所などによる資金提供；STARRT-AKI ClinicalTrials.gov番号、NCT02568722）。

CONCLUSIONS: Among critically ill patients with acute kidney injury, an accelerated renal-replacement strategy was not associated with a lower risk of death at 90 days than a standard strategy. (Funded by the Canadian Institutes of Health Research and others; STARRT-AKI ClinicalTrials.gov number, NCT02568722.).

Copyright © 2020 Massachusetts Medical Society.