jRCT1030210695招募中不适用
Hyperkalemia registry An observational prospective cohort study for long-term management of hyperkalemia in patients with chronic kidney disease or heart failure (HK registry main)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 主要终点
- patterns of treatment for hyperkalemia
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •a) Aged >=20 years
- •b) Patients with hyperkalemia who meet the following criteria
- •i) Being treated with potassium binders for hyperkalemia at the time of enrolment,and having started receiving potassium binders within 6 months before enrolment
- •c) Having been diagnosed as CKD(>=stage 3b) or HF diagnosed by investigators,and as defined below
- •c-1) CKD is diagnosed based on the CKD guidelines issued by the Japanese Society of Nephrologyxxv as being either or both of condition 1 and 2 for >=3 months
- •i) Clear signs of kidney impairment based on the results of urinalysis,imaging,blood test,or biopsy.Presence of proteinuria,especially more than 0.15g/gCr(albuminuria more than 30mg/gCr).
- •ii) GFR <45 mL/min/1.73m2
- •In routine clinical practice,GFR is estimated using serum creatinine,gender,and age,according to the following equation.
- •eGFR creat (mL/min/1.73m2) = 194 x serum creatinine (mg/dL)-1.094 x age (years)-0.287 (for female patients, x 0.739)
- •Stage 3b of CKD,or higher,defined based on the following eGFR categories
- •i) Stage 3b 30 mL/min/1.73m2 less than or equal to eGFR <45 mL/min/1.73m2
- •ii) Stage 4 15 mL/min/1.73m2 less than or equal to eGFR <30 mL/min/1.73m2
- •iii) Stage 5 eGFR <15 mL/min/1.73m2
- •c-2) Patients with HFwill be enrolled if patients meet following criteria
- •i) NYHA class II-IV,within 6 months
- •ii) Patients with a diagnosis or history of heart failure,hospitalization,and laboratory records of any of the following
- •NT-proBNP>=400 pg/ml or BNP>=100 pg/ml,or pathological findings such as abnormal cardiac function by UCG/CT/MRI/catheterization/nuclear medicine examination
- •d) Provision of signed,written,and detailed informed consent
排除标准
- •a) Currently on any chronic RRT(including hemodialysis or peritoneal dialysis >30 days,or kidney transplant)within 6 months before enrolment
- •b) Patients with acute kidney injury(AKI)* within 6 months before enrolment
- •c) Patients with acute heart failure within 3 months before enrolment
- •d) Patients who received blood transfusion within 6 months before enrolment
- •e) Patients with active malignancy or whose life expectancy is less than 6 months
- •f) GI disturbance,chronic diarrhoea,or GI stoma if,as judged by the investigators,that condition or its treatment has an important impact on S-K values
- •g) Autoimmune disease if,as judged by the investigators,that condition or its treatment has an important impact on S-K values
- •h) Patients who are suspected,on the basis of laboratory data,to have pseudohyperkalemia(abnormality in the sample,a history of severe leukocytopenia or thrombocytopenia)
- •i) Patients with recent traumatic injury
- •j) Patients who are pregnant,lactating,or planning to become pregnant
- •k) Current participation in a clinical trials,i.e.an interventional studies
- •l) Presence of a condition that,in the opinion of the investigator,
- •i) would places the subject at undue risk,or
- •ii) would potentially jeopardizes the quality of the data to be generated,or
- •iii) would prevent the patient from performing protocol-defined tasks for physical or mental reasons,or
- •iv) would prevent the patient from understanding the contents of the self-administered questionnaire and responding to its questions on his/her own,or
- •v) would,for some other reason,make the patient inappropriate for this study.
- •AKI is diagnosed if at least one of the following three conditions is met.Note:This follows KDIGO clinical guidelines.
- •1.Delta sCr >= 0.3 mg/dL(within 48 hours)
- •2.1.5 x increase from the baseline value of sCr(within 7 days)
- •3.Urine volume 0.5 mL/kg/hr or less,lasting more than 6 hours
结局指标
主要结局
patterns of treatment for hyperkalemia
To describe patterns of treatment for hyperkalemia (High-K)
associations between patterns of treatment for High-K and HR-QoL, adherence, and burden of treatment
To assess associations between patterns of treatment for High-K and HR-QoL, adherence, and burden of treatment
associations of HR-QOL and of adherence to prescriptions of medications with S-K control
To assess associations of HR-QOL and of adherence to prescriptions of medications with S-K control
次要结局
- nutritional status(at baseline and during follow-up)
- status of metabolic acidosis(at baseline and during follow-up)
- use of healthcare resources
研究者
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