L-carnitine on the Prevention of Renal Scarring in Acute Pyelonephritis
Status:
Unknown status
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
Risk factors for parenchymal damage in urinary tract infection are vesicoureteral reflux
(VUR),obstructive uropathy,the number of flares of acute pyelonephritis(APN) and delay in
treatment of acute infection.The pathogenesis of APN is related to bacterial
virulenece,immune response,tissue factors,apoptosis and production of free radicals that lead
to fibrosis and renal scarring. Oxidative stress in renal cells may be a critical factor in
the pathogenesis of pyelonephritis whereas pharmacological management of the oxidative stress
response may provide a therapeutic effect in preventing renal pathologies. Animal model show
that L-carnitine alleviated oxidative stress, and acute renal inflammatory injury can be
prevented much more effectively by carnitine in addition to conventional antibiotic treatment
in pyelonephritis.This study is a simple randomized clinical trial (RCT) evaluating the
effect of L-carnitine in addition to antibiotic on preventing renal scaring after acute
pyelonephritis in children. Simple non- blind randomized clinical trial on 78 patients in 2
groups (intervention & control) is conducted.Children aged 1 month to 10 years with positive
urine culture, clinical findings, and 99mTc-dimercaptosuccinic acid (DMSA) scintigraphy-based
evidence in favor of acute pyelonephritis were enrolled into a clinical trial. Patients were
excluded if they had neurogenic bladder, systemic hypertension, obstructive uropathy.
Patients in Intervention group are administered 50 mg/kg/day carnitine in divided 2-3
times/day (maximum 3 g/day) in addition to antibiotic regimens and patients in control group
received antibiotic regimens. Primary outcome is the development of renal scar by doing DMSA
renal scan on the 7th day of admission and six months after the intervention and compared
between groups and secondary outcome is the incidence and severity of pyelonephritis and
response to treatment.