ABSTRACT
Background: Nephrotic syndrome is a clinical
condition characterized by massive urinary loss of
protein, primarily albumin, which leads to
hypoproteinemia (hypoalbuminemia) and edema. In
childhood nephrotic syndrome, the most common
complications are those secondary to hypovelemia and
edema. Clinically apparent edema is usually not seen
until serum albumin levels drop below 2 g/dl. Standard
treatment has been loop diuretics with aldosterone
antagonist such as spironolactone. If these fail, then
intravenous 20% albumin with furosemide is usually
used. The usefulness of albumin in the treatment of
nephrotic syndrome in combination with furosemide is
controversial and has not been proven.
Objective: To compare the efficacy of albuminpost
infusion furosemide and albumin-furosemide
incorporation in decreasing nephrotic edema in children.
Study Design: Randomized Controlled Trial
Methodology: This is a single blinded prospective
study with randomly selected children using simple
random sampling. The population considered for
inclusion in this study were newly diagnosed idiopathic
nephrotic syndrome children ages 1-16 years with
anasarca and in relapse. Patients with secondary
nephrotic syndrome, such as with clinical features of
systemic lupus erythematosus, Henoch Schonlein
purpura, and/or evidence of systemic disease were
excluded. The study was performed during relapse and
the patients were admitted. Informed consents were
obtained from the parent or guardian prior to the therapy.
The 17 subjects were randomized to “Group A”
which received albumin-post infusion furosemide while
the other 17 subjects were randomized to “Group B”
which received albumin-furosemide incorporation. The
following parameters were recorded: heart rate (beats/
min), body weight (kg.), abdominal circumference (CM),
pretibial edema (-/4+), urine output (ml/k/hr), hematocrit
(%), serum albumin (mg/dl) and blood pressure (mm Hg)
observed at 0, 6 and 24 hours from infusion.Urine output
in cc/kg was measured at 8, 16 and 24 hours after
infusion. The therapy protocol used in this study was 1g/
kg albumin to run for 1 hour intravenously followed by
furosemide to be given at 2 mg/k/dose as slow
intravenous push immediately after infusion for Group A.
Group B received same doses of albumin and
furosemide; however, furosemide was incorporated to
the albumin solution and this was infused for 1 hour.
Statistical analyses were performed in Statistical
Package for the Social Sciences software (SPSS
version 10). Chi-square and independent t-tests were
used to describe sex, age, and height distribution
between the two groups. Repeated measures ANOVA
were employed to test for the difference in the means
between treatment groups and across time. Difference in
means at each time measurement and changes in the
parameters from the baseline to 6 hours and 24 hours
post-infusion were evaluated using independent t-tests.
Differences in pretibial edema between treatment groups
and across time were evaluated using Friedman test.
The Mann-Witney U test were used to test the difference
of the pretibial edema between the groups in each time
measurement. A p-value of <0.05 was considered
statistically significant.
Results: Thirty-four (34) children were included in
the study. The mean age for “Group A” (albumin postinfusion
furosemide group) was 8.9 years (SD + 4.3)
while the mean age for “Group B” (albumin-furosemide
incorporation group) was 8 years (SD + 4.7). There were
male children in Group A (58.8%) compared to Group B
(41.2%) Test for differences in distribution of males and
females, mean age and mean height between the two
groups were not significant (p value >0.05).The decrease
in heart rates, abdominal circumference, pretibial edema,
hematocrit and change in serum albumin level from
baseline to 24 hours infusion were significant with the pvalues
of 0.001, 0.000, 0.000, 0.000, 0.000 respectively
in both groups. The mean urine output between the two in body weight from baseline to 2 hours after infusion
was significant in both groups. Only 1 male patient
belonging to Group A developed itchiness.
Conclusion: The efficacy of albumin-post infusion
furosemide is comparable to albumin-furosemide
incorporation in decreasing nephrotic edema, specifically
in decreasing the body weight and abdominal
circumference. There was significant increase in urine
output in both groups. No serious side effects were
noted except for 1 case of pruritus.
Keywords: Nephrotic Syndrome, nephrotic edema
albumin, furosemide, relapse |