Critical appraisal
Clinical and cost-effectiveness of oral sodium bicarbonate therapy for older patients with chronic kidney disease and low-grade acidosis (BiCARB): a pragmatic randomised, double-blind, placebo-controlled trial
I- sodium bicarbonate 3gm/day for 2 years
C - placebo
O - Outcomes :
We measured outcomes at baseline and 3, 6, 12 and 24
months. The primary outcome was the between-group
difference in the Short Physical Performance Battery
(SPPB) at 12 months, adjusted for baseline values. The
SPPB is a 12-point measure of lower limb strength and
balance, with higher values denoting better function,
that predicts future disability, need for care and death. The minimum clinically important difference
has been derived for the measure [16].
Secondary outcome measures were generic (EuroQoL
EQ-5D-3L) [19] and disease-specific (Kidney Disease
Quality of Life) [20] health-related quality of life,
anthropometry (weight, mid-arm muscle circumference, triceps
skinfold thickness, mid-thigh circumference), physical
performance (6-min walk speed, grip strength) and renal
function
Our results suggest that at least for patients aged 60 and
over with CKD GFR categories 4 and 5, 1.5 to 3 g per day
of oral bicarbonate does not produce any health benefits
and may be associated with net harms. Whilst other indica-
tions for control of acidosis exist (for example high potas-
sium concentrations), evidence from the current trial
suggests that the additional cost, treatment burden and side
effects of oral bicarbonate may not justify its use in older
people with advanced CKD and mild degrees of metabolic
acidosis (i.e. serum bicarbonate concentration < 22 mmol/
L). Raising bicarbonate levels by an amount sufficient to
produce useful clinical effects will require larger doses than
we used in this trial and is likely to require a ‘treat-to-target’
strategy. However, such doses may not be tolerated by
many older people. Alternative strategies, such as the use of
hydrochloric acid binders, may provide a way round this
issue, but such agents need to be tested against current
practice in representative groups of patients, using a range
of outcomes relevant to older people including physical
function, quality of life and deterioration of renal function
Comments
Post a Comment