Clinical trial NCT02614807: Protein Supplementation in Thiazide-induced Hyponatremia
Official title: Thiazide Diuretic-caused Hyponatremia in the Elderly Hypertensive: Will a Bottle of Nepro a Day Keep Hyponatremia and the Doctor Away? A Proof-of-Concept Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hyponatremia
Hypertension
Blood Pressure
Keywords: Dietary Supplement
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: High blood pressure is very common among elderly Canadians. Clinical trials show clear benefit from lowering blood pressure in hypertensive elderly patients. These trials also demonstrate safety for several classes of blood pressure lowering drugs including water pills. However, water pills (thiazide diuretics) used for treatment of hypertension, can cause low sodium (hyponatremia), a significant clinical problem mainly among elderly and very elderly. Causes are age related decrease in kidneys' ability to get rid of water and low salt coupled with high water intake. A standard approach to treatment is lacking since higher salt intake may worsen hypertension, and lower water and higher protein intake is difficult to understand and actually implement. 'Nepro' is a nutritional drink high in protein, and low in potassium and sodium. It is used frequently as a dietary supplement in patients with kidney disease specifically for low sodium and high protein content. The high protein content in Nepro can help the kidney get rid of excess water, and the low sodium and potassium content will make this a safe option to use. Hence investigators propose a proof-of-concept trial on an easy to understand and administer, and relatively affordable solution to this issue. It could be summarized in one sentence: "Will a bottle of Nepro a day keep thiazide-caused hyponatremia and the doctor away?"


Eligibility criteria: Inclusion Criteria:

* Elderly (\>65 years old)
* with diagnosed hypertension (HTN) treated with thiazide (hydrochlorothiazide) or thiazide-like (chlorthalidone and indapamide) diuretic and
* mild to moderate hyponatremia (Plasma sodium concentration 125-133 mmol/L).

Exclusion Criteria:

* Pregnancy
* estimated glomerular filtration rate (eGFR) \<45 ml/min/1.75 m2,
* Other causes of hyponatremia (liver cirrhosis, uncontrolled hypothyroidism, adrenal insufficiency)
* unable to provide informed consent;
* patients with generalized volume overload who may require immediate changes in diuretic therapy (at the discretion of treating HTN specialist);
* patients taking drugs which may interfere with urinary sodium excretion (such as carbamazepine, loop diuretics, potassium sparing diuretics, mineralocorticoid and glucocorticosteroids, selective serotonin receptor inhibitors, tricyclic antidepressants, amiodarone, and lithium);
* patients with moderate to severe hyponatremia (Plasma sodium concentration \< 125 mmol/L) who may require immediate discontinuation of the thiazide diuretic .

Primary outcomes:
measure: Efficacy: Correction of Hyponatremia (Serum Sodium > 133 mmol/L or reduction of deficit by 50%)
timeFrame: 4 weeks
Secondary outcomes:
measure: Feasibility: recruitment (proportion of patients who are screened and eligible, and proportion eligible who consent)
timeFrame: 4 weeks
measure: Safety: Tolerability of intervention (proportion of patients who can tolerate the Nepro supplement)
timeFrame: 2 and 4 weeks
measure: Safety: Worsening of hyponatremia (proportion of patients with Sodium < 125 mmol/L at 2 or 4 weeks)
timeFrame: 2 and 4 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Marcel Ruzicka, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruzicka M, McCormick B, Magner P, Ramsay T, Edwards C, Bugeja A, Hiremath S. Thiazide diuretic-caused hyponatremia in the elderly hypertensive: will a bottle of Nepro a day keep hyponatremia and the doctor away? Study protocol for a proof-of-concept feasibility trial. Pilot Feasibility Stud. 2018 Apr 6;4:71. doi: 10.1186/s40814-018-0263-y. eCollection 2018.