Hyperkalemia registryAn observational prospective cohort study for long-term management of hyperkalemia in patients with chronic kidney disease or heart failure
- Conditions
- Hyperkalemia
- Registration Number
- JPRN-jRCT1030210695
- Lead Sponsor
- Morita Naru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 350
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) To describe patterns of treatment for hyperkalemia (High-K)<br>2) To assess associations between patterns of treatment for High-K and HR-QoL, adherence, and burden of treatment<br>3) To assess associations of HR-QOL and of adherence to prescriptions of medications with S-K control
- Secondary Outcome Measures
Name Time Method 1) To assess the nutritional status of patients with hyperkalemia at baseline and during follow-up<br>2) To assess the status of metabolic acidosis at baseline and during follow-up<br>3) To describe the use of healthcare resources in patients with hyperkalemia