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TRACK的设计与队列特征,一项关于高钾血症管理决策的前瞻性研究。

Design and cohort characteristics of TRACK, a prospective study of hyperkalaemia management decision-making.

作者信息

Hsia Judith, Shivappa Nitin, Bakhai Ameet, Bover Jordi, Butler Javed, Ferraro Pietro Manuel, Fried Linda, Schneider Markus P, Tangri Navdeep, Winkelmayer Wolfgang C, Bishop Meredith, Chen Hungta, Sundin Anna-Karin, Bonaca Marc P

机构信息

CPC Clinical Research, University of Colorado, Aurora, CO, USA.

AstraZeneca, Wilmington, DE, USA.

出版信息

Clin Kidney J. 2024 Sep 30;17(10):sfae295. doi: 10.1093/ckj/sfae295. eCollection 2024 Oct.

Abstract

BACKGROUND

Guideline-recommended hyperkalaemia management includes dietary potassium (K) restriction, bicarbonate correction, diuretics and K binders with dose reduction of renin-angiotensin-aldosterone system inhibitors as a last resort. The extent to which these recommendations are implemented is uncertain, as real-world data on hyperkalaemia management are limited. The Tracking Treatment Pathways in Adult Patients with Hyperkalemia (TRACK) study is a multinational, prospective, longitudinal study that is being conducted to address this knowledge gap. We report the design and baseline cohort characteristics of this real-world study of hyperkalaemia management decision-making.

METHODS

This study enrolled participants within 21 days of an episode of hyperkalaemia in four European countries (UK, Spain, Germany, Italy) and the USA. During the 12-month follow up, data collected will include participant and healthcare provider characteristics (specialty and practice setting), hyperkalaemia treatment objectives and strategies, rationale for management decisions and indicators of response and patient-reported perceptions of their hyperkalaemia treatment.

RESULTS

The enrolled cohort includes 1330 participants, mean age 68 years, of whom 31% were women. At baseline, 6% reported heart failure, 55% chronic kidney disease, 29% both and 9% neither. Most participants (57%) were taking an angiotensin-converting enzyme inhibitor, angiotensin receptor blocker or angiotensin receptor/neprilysin inhibitor at baseline. Mineralocorticoid receptor antagonist use was lower (14%).

CONCLUSIONS

The prospective TRACK study will shed light on practitioners' hyperkalaemia management decision-making and assess the impact of their decisions on hyperkalaemia recurrence. Understanding practitioners' underlying thought processes will facilitate efforts to improve hyperkalaemia management.ClinicalTrials.gov: NCT05408039.

摘要

背景

指南推荐的高钾血症管理措施包括限制饮食中钾(K)的摄入、纠正碳酸氢盐、使用利尿剂和钾结合剂,作为最后手段可减少肾素 - 血管紧张素 - 醛固酮系统抑制剂的剂量。由于高钾血症管理的真实世界数据有限,这些建议的实施程度尚不确定。成人高钾血症患者治疗路径追踪(TRACK)研究是一项多国、前瞻性、纵向研究,旨在填补这一知识空白。我们报告这项高钾血症管理决策真实世界研究的设计和基线队列特征。

方法

本研究在四个欧洲国家(英国、西班牙、德国、意大利)和美国招募了在高钾血症发作21天内的参与者。在12个月的随访期间,收集的数据将包括参与者和医疗保健提供者的特征(专业和执业环境)、高钾血症治疗目标和策略、管理决策的理由以及反应指标和患者报告的对其高钾血症治疗的看法。

结果

入组队列包括1330名参与者,平均年龄68岁,其中31%为女性。基线时,6%报告有心力衰竭,55%有慢性肾脏病,29%两者皆有,9%两者皆无。大多数参与者(57%)在基线时正在服用血管紧张素转换酶抑制剂、血管紧张素受体阻滞剂或血管紧张素受体/脑啡肽酶抑制剂。盐皮质激素受体拮抗剂的使用较少(14%)。

结论

前瞻性的TRACK研究将揭示从业者的高钾血症管理决策,并评估他们的决策对高钾血症复发的影响。了解从业者的潜在思维过程将有助于努力改善高钾血症管理。ClinicalTrials.gov:NCT05408039。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9072/11503019/58c1499d072b/sfae295fig1.jpg

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