Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Controlled and Prospective Pilot Study on the Effects of Intensified Sodium Management on Hospitalization in Chronic Hemodialysis Patients.
Brief Summary: The primary aim of this study is to investigate whether intensive sodium management by dietary sodium restriction and by preventing positive sodium balance during dialysis can be successfully applied in chronic hemodialysis patients. Secondary aims are to test if sodium restriction has positive effects on the frequency of hospital admissions, blood pressure, fluid overload, quality of life and residual renal function.


Options:
A: Inclusion Criteria:

* Be 18 years or older.
* Have chronic kidney disease (CKD stage 1-3, CKD 4 if eGFR is not lower than 25 mL/min/1.73m2, or be a renal transplant recipient.)
* Have a urinary sodium excretion during at least the last 2 subsequent visits of more than 130 mmol per day, or one last urinary sodium excretion of more than 150 mmol per day.
* Have a systolic blood pressure higher than 135 mmHg, diastolic blood pressure higher than 85 mmHg or a well-controlled blood pressure by treatment with antihypertensives including RAAS-blockade (ACE-inhibitor or ARB).
* Sufficient command of the Dutch language.
* Access and ability to use the internet.
* Written informed consent.

Exclusion Criteria:

* eGFR \< 25 ml/min/1.73m2 or an anticipated need for predialysis work-up within the time frame of the study.
* Unstable disease: defined as rapid, persistent, progressive renal function loss (e.g. \> 6 mL/min/1.73m2 per year), not from acute, intermittent origin.
* Blood pressure \> 170 mmHg systolic or \> 100 mmHg diastolic during medical treatment
* Blood pressure \< 95 mmHg systolic not responding to withdrawal of antihypertensives.
* Cardiovascular event (myocardial infarction, cerebrovascular accident) \< 6 months ago.
* Renal transplantation \<1 year ago.
* Medical conditions that are likely to interfere with completion of the study (such as progressive malignancy or other debilitating illness) at the discretion of the nephrologist.
* Every patient who has participated in the ESMO study (regardless whether intervention or control) cannot participate in the current study.
* Current participation in any clinical trial that might interfere with SUBLIME trial.
B: Inclusion Criteria:

* Age 40 years or older
* MDRD eGFR of 30-60ml/min/1.73m2 on ≥2 occasions ≥3 months apart
* Most recent eGFR measurement within 3 months Systolic blood pressure \<160mmHg and diastolic blood pressure \<95mmHg on three office blood pressure readings at time of screening and confirmed by a study ABPM before randomisation of \<150/90mmHg
* No change in anti-hypertensive or diuretic medications (including dose) for 3 months before screening visit
* Consumption of moderate sodium intake at screening, defined as an estimated daily sodium intake of \>2.3g/day estimated from food frequency questionnaire (FFQ) completed during the screening visit
* Self-reported willingness to modify dietary intake over sustained period, and adhere to directed recommendations over 2 years
* Signed written informed consent

Exclusion Criteria:

* Acute Kidney Injury in the preceding three months, defined as doubling of baseline serum creatinine or rapidly declining eGFR over the preceding six months, defined as a decline in eGFR of ≥10ml/min/1.73m2 in those with established CKD
* Any of the following renal conditions: glomerular disease due to post-infectious glomerulonephritis, IgA nephropathy, thin basement membrane disease, Henoch-Schonlein purpura, proliferative glomerulonephritis, membranous nephropathy (including lupus nephritis), rapidly progressive glomerulonephritis, minimal change disease, or focal segmental glomerulosclerosis
* Prior or planned renal transplantation
* Prior, current or planned renal dialysis
* Medical diagnosis known to be associated with abnormal renal sodium excretion, including Bartter syndrome, SIADH, diabetes insipidus, or serum sodium \<125mmol
* Severe heart failure (defined as left ventricular ejection fraction ≤30% or NYHA Class III/IV symptoms)
* High-dose loop or thiazide diuretic therapy, exceeding a total daily dose of frusemide 80mg, bumetanide 2mg, hydrochlorothiazide 50mg, bendroflumethiazide 2.5mg, indapamide 2.5mg, metolazone 2.5mg or the use of both a loop and thiazide diuretic
* Current use of non-steroidal anti-inflammatory drugs (NSAIDs) for 3 or more days per week. Low-dose aspirin \<100mg/day is not an exclusion
* Unable to follow educational advice of the research team
* Prescribed high-salt diet, low-salt diet or sodium bicarbonate
* Symptomatic postural hypotension or receiving treatment for postural hypotension
* Current or recent use (within one month) of immunosuppressive medications including tacrolimus, cyclosporine, azathioprine or mycophenolate mofetil
* Pregnancy or lactation
* Unable to comply with 24-hour urinary collections, or medical condition making collection of 24-hour urinary collection difficult (e.g. severe urinary incontinence)
* Participant unlikely to comply with study procedures or follow-up visits due to severe co-morbid illness or other factor (e.g. inability to travel for follow-up visits, drug or alcohol misuse) in opinion of research team
* Cognitive impairment defined as a known diagnosis of dementia, or inability to provide informed consent due to cognitive impairment in the opinion of the investigator
* Body Mass Index (BMI) \<20kg/m2 or BMI\>40kg/m2
* Participating in another clinical trial or previous allocation in this study
C: Inclusion Criteria:

* Ambulatory, clinically stable maintenance hemodialysis patients on a thrice weekly HD regimen.
* Willing and able to provide written, signed informed consent after the nature of the study has been explained.
* Willing and able to comply with all study procedures.
* Age ≥18 years.

Exclusion Criteria:

* Simultaneous participation in another clinical study except observational trials.
* Any psychological condition which could interfere with the patient's ability to comply with the study protocol.
* Pregnancy.
* Amputation of a limb.
* Pacemaker, implantable pump, artificial joint.
* Expectation that native kidney function will recover.
* Unable to verbally communicate in English or Spanish.
* Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center within the next 14 months.
* Life expectancy \< 15 months
D: Inclusion Criteria:

The investigators will recruit those individuals:

* who are 18 years of age or older,
* who are literate, community-dwelling adults, and
* who have been receiving maintenance PD for at least 3 months. Individuals on maintenance PD less than 3 months are excluded to allow for patients to adjust to the PD regimen, and for stabilization of nutritional status in the early weeks of dialysis (i.e. they may be considered for the study after 3 months of dialysis)

Exclusion Criteria:

Excluded from the study will be individuals:

* who are deemed by dialysis center staff to have a problem with cognitive function and to be chronically noncompliant to the dialysis regimen (e.g. misses multiple appointments and dialysis treatments),
* those who cannot read or write, those who do not speak English,
* those who plan to move out of the area or change dialysis centers within the next 5 months,
* those with a terminal illness and life expectancy of less than 12 months,
* those who are scheduled for a living donor transplant,
* individuals who cannot see the PDA screen or use the stylus to make selections from the PDA screen, or
* individuals who are living in a nursing home or personal care facility, who would have limited control over their dietary intake

Answer: C