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标准与碳酸适应型肾脏替代治疗在高碳酸血症性 ARDS 患者中的比较:一项随机对照试验(BigBIC)。

Standard vs. carbone dioxide adapted kidney replacement therapy in hypercapnic ARDS patients: a randomized controlled pilot trial (BigBIC).

机构信息

Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt Universität zu Berlin and Berlin Institute of Health, Augustenburger Platz 1, 13353, Berlin, Germany.

Department of Nephrology, University Medical Center Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany.

出版信息

Crit Care. 2024 Jun 11;28(1):198. doi: 10.1186/s13054-024-04979-z.

DOI:10.1186/s13054-024-04979-z
PMID:38863072
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11167756/
Abstract

BACKGROUND

Current continuous kidney replacement therapy (CKRT) protocols ignore physiological renal compensation for hypercapnia. This study aimed to explore feasibility, safety, and clinical benefits of pCO2-adapted CKRT for hypercapnic acute respiratory distress syndrome (ARDS) patients with indication for CKRT.

METHODS

We enrolled mechanically ventilated hypercapnic ARDS patients (pCO2 > 7.33 kPa) receiving regional citrate anticoagulation (RCA) based CKRT in a prospective, randomized-controlled pilot-study across five intensive care units at the Charité-Universitätsmedizin Berlin, Germany. Patients were randomly assigned 1:1 to the control group with bicarbonate targeted to 24 mmol/l or pCO-adapted-CKRT with target bicarbonate corresponding to physiological renal compensation. Study duration was six days. Primary outcome was bicarbonate after 72 h. Secondary endpoints included safety and clinical endpoints. Endpoints were assessed in all patients receiving treatment.

RESULTS

From September 2021 to May 2023 40 patients (80% male) were enrolled. 19 patients were randomized to the control group, 21 patients were randomized to pCO-adapted-CKRT. Five patients were excluded before receiving treatment: three in the control group (consent withdrawal, lack of inclusion criteria fulfillment (n = 2)) and two in the intervention group (lack of inclusion criteria fulfillment, sudden unexpected death) and were therefore not included in the analysis. Median plasma bicarbonate 72 h after randomization was significantly higher in the intervention group (30.70 mmol/l (IQR 29.48; 31.93)) than in the control group (26.40 mmol/l (IQR 25.63; 26.88); p < 0.0001). More patients in the intervention group received lung protective ventilation defined as tidal volume < 8 ml/kg predicted body weight. Thirty-day mortality was 10/16 (63%) in the control group vs. 8/19 (42%) in the intervention group (p = 0.26).

CONCLUSION

Tailoring CKRT to physiological renal compensation of respiratory acidosis appears feasible and safe with the potential to improve patient care in hypercapnic ARDS.

TRIAL REGISTRATION

The trial was registered in the German Clinical Trials Register (DRKS00026177) on September 9, 2021 and is now closed.

摘要

背景

目前的持续肾脏替代治疗(CKRT)方案忽略了肾脏对高碳酸血症的生理代偿。本研究旨在探讨针对需要 CKRT 的高碳酸血症急性呼吸窘迫综合征(ARDS)患者,碳酸根适应性 CKRT 的可行性、安全性和临床获益。

方法

我们在德国柏林夏洛蒂医科大学的五个重症监护病房进行了一项前瞻性、随机对照的初步研究,纳入了接受局部枸橼酸抗凝(RCA)的机械通气高碳酸血症 ARDS 患者(pCO2 > 7.33 kPa)。患者被随机分为 1:1 比例的对照组和碳酸根适应性 CKRT 组,对照组的目标碳酸氢盐为 24 mmol/l,而碳酸根适应性 CKRT 组的目标碳酸氢盐则对应于生理肾脏代偿。研究持续 6 天。主要结局为 72 小时后的碳酸氢盐水平。次要终点包括安全性和临床终点。所有接受治疗的患者都进行了终点评估。

结果

从 2021 年 9 月至 2023 年 5 月,共有 40 名患者(80%为男性)入组。其中 19 名患者被随机分配到对照组,21 名患者被随机分配到碳酸根适应性 CKRT 组。有 5 名患者在接受治疗前被排除:对照组 3 名(撤回同意、不符合纳入标准(n = 2)),干预组 2 名(不符合纳入标准、突然意外死亡),因此未纳入分析。随机分组后 72 小时的血浆碳酸氢盐中位数在干预组明显更高(30.70 mmol/l (IQR 29.48; 31.93)),而在对照组为 26.40 mmol/l (IQR 25.63; 26.88);p < 0.0001)。干预组有更多的患者接受了潮气量<8 ml/kg 预测体重的肺保护性通气。对照组 30 天死亡率为 16/19(63%),而干预组为 19/21(42%)(p = 0.26)。

结论

针对呼吸性酸中毒的肾脏生理代偿来调整 CKRT 似乎是可行和安全的,有可能改善高碳酸血症 ARDS 患者的治疗效果。

试验注册

该试验于 2021 年 9 月 9 日在德国临床试验注册处(DRKS00026177)注册,现已关闭。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dce6/11167756/dc9018fd5b31/13054_2024_4979_Fig4_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dce6/11167756/dc9018fd5b31/13054_2024_4979_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dce6/11167756/44ea625ced14/13054_2024_4979_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dce6/11167756/fcd79e0a15dc/13054_2024_4979_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dce6/11167756/e84d35346e9c/13054_2024_4979_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dce6/11167756/dc9018fd5b31/13054_2024_4979_Fig4_HTML.jpg

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