IMpact of hyPeRkalaemia on thErapy With Renin angiotenSin aldoSterone System Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of patients who take RAASi without clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia.
研究概览
简要总结
There are limited data regarding the burden of hyperkalaemia in patients attending emergency departments (ED) or who are hospitalised (excluding those already receiving dialysis). Renin-angiotensin-aldosterone system inhibitors (RAASi) are of prognostic benefit in patients with heart failure with reduced ejection fraction (HFrEF) and post myocardial infarction (MI) left ventricular systolic dysfunction (LVSD) and as such should be continued wherever possible for these indications. These drugs may contribute to elevation in serum potassium and hyperkalaemia may lead to a reduction in dose or complete withdrawal of RAASi. Yet it remains unknown how common this happens in standard clinical practice. Inappropriate discontinuation of RAASi in such patients may lead to adverse clinical outcomes. If patients have hyperkalaemia that limits the use of RAASi, they may be candidates for new potassium binders that could facilitate their continued use.
详细描述
Research questions:
In an adult population of patients who are hospitalised or attending the emergency department (and not receiving dialysis) with hyperkalaemia:
- How does hyperkalaemia impact on RAASi therapy and does this vary according to the clinical indication for the drug(s)?
- What are the demographics, co-morbidities and drug history for patients presenting with hyperkalaemia?
- What is the frequency of subsequent hospitalisations and mortality rate in a cohort of patients presenting with hyperkalaemia at 12 months?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in ED or inpatients with at least 1 blood test with a potassium level of ≥5.5 mmol/l
- •Receiving RAASi.
- •Aged 18 and above.
- •Able to provide informed consent or consent provided by consultee in those unable to consent for themselves.
排除标准
- •Patients already receiving dialysis prior to the episode of hyperkalaemia.
- •For patients considered for postal consent: known cognitive impairment, learning difficulties or brain injury or those who had transient cognitive impairment, delirium or required urgent deprivation of liberty form completion during inpatient stay or in the previous 12 months prior to hyperkalaemia episode.
结局指标
主要结局
Proportion of patients who take RAASi without clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia.
时间窗: 12 months
Proportion of hospitalised patients/ED attenders receiving RAASi without clear prognostic indication who experience RAASi dose reduction/withdrawal due to hyperkalaemia at discharge.
Proportion of patients who take RAASi for clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia.
时间窗: 12 months
Proportion of hospitalised patients/ED attenders receiving RAASi for clear prognostic indication who experience RAASi dose reduction/withdrawal due to hyperkalaemia at discharge.
次要结局
- Recurrent hyperkalaemias.(12 months)
- Proportion of patients continuing of RAASi.(3 months and 12 months)
- Mortality(12 months)
- Level of hyperkalaemia leading to changes to RAASi.(12 months)
- Hospitalisations(12 months)