Dietary Sodium Intake and Blood pressure in Living Kidney Donors (SPLID Trial)

UCI Specialty Area: Nephrology

Principal Investigator: Ekamol Tantisattamo

Official Title: Dietary Sodium Intake and Blood pressure in Living Kidney Donors: A Pilot Single-Center Crossover Single-Blind Randomized Controlled Trial (SPLID Trial)

A Study On:

Kidney - Nephrology

Kidney Donor

Study Description

This is a pilot study to determine the feasibility of the study design and examine the main outcome whether low dietary sodium intake <2.3 g/day (<100 mmol/day) is superior to high dietary sodium intake >/= 4 - <6 g/day (>/= 174 - <261 mmo/day) in controlling blood pressure (BP) to be within normotensive range, lowering systolic and diastolic blood pressures (SBP and DBP) from the baseline blood pressures, and decreasing the risk of hypertension, worsening kidney function, and proteinuria in living kidney donors between 5 and 12 months after living kidney donation.

Eligibility

Living kidney donors who underwent a living kidney donation at least 5 months ago but not more than 12 months
Age >/= 18 years old
Agree to perform the procedure as per study protocol (Table 1)
Living kidney donors with an average sitting SBP <160 mmHg at 5-month post-donation measured by automatic office blood pressure (AOBP)
Able to sign informed consent
Able to attend all research visits
Woman using birth control methods other than hormonal contraception

History of previous cardiovascular (CV) events including acute MI, HF, and stroke
Symptomatic heart failure within 5 months after living kidney donation or left ventricular ejection fraction (by any method) <35%
CV event or procedure or hospitalization for hypertensive-related disorders within 5 months after living kidney donation
Diagnosed with HTN or on antihypertensive medication(s) before living kidney donation
Patients who are supposed to take BP lowering medications for reasons other than BP control but do not take those medications or take them with in appropriate doses
Arm circumference is too small or large to allow accurate BP measurement with available 24-h ABPM machines.
An average standing SBP ≥160 mmHg at 5-month post-donation measured by automatic office blood pressure (AOBP)
Albuminuria that equals or is equivalent to 1 g per day by using spot urinary albumin per urine creatinine ratio (UACR) or 24-hour urinary albumin excretion rate by a 24-hour urine collection within 5 months post-donation
Advanced kidney function defined by estimated glomerular filtration rate (eGFR) by using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation22 of <20 ml/min/1.73m2 or requiring dialysis after living kidney donation
Drink coffee > two 8-ounce (237 mL) cup a day or equivalence
Drinks alcohol >3 drinks/day or >30 ml/day
Smoking cigarette >/=10 cigarettes/day
Take Nonsteroidal anti-inflammatory drugs (NSAIDS)
Use hormone replacement therapy or oral contraceptives
Pregnancy, currently trying to become pregnant
Using birth control pills
A medical condition likely to limit survival to less than 2 years
Any factors that are likely to limit adherence to interventions.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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