Acute Pyelonephritis(APN) Clinical Trial
Urinary tract infections (UTI) are a common and important clinical problem in
childhood.Upper urinary tract infections (ie, acute pyelonephritis) may lead to renal
scarring, hypertension, and end-stage renal disease.Pathogenesis of acute pyelonephritis
(APN) is associated with urinary tract anatomy and function, bacterial virulence factors,
the host innate immune system and production of free radicals. Oxygen-free radicals and
oxidative stress play a role in renal scar formation after an APN. Oxygen-free radical
scavengers and antioxidants can reduce tissue damage and renal scaring during acute
pyelonephritis.we want to publish a study that indicates that antioxidant therapy with
omega-3 given to children with pyelonephritis may indeed lower the risk for renal scarring.
Several studies show that omega-3 alleviated oxidative stress and inflammation.This study is
a simple randomized clinical trial (RCT) evaluating the effect of omega-3 in addition to
antibiotic on preventing renal scaring after acute pyelonephritis in children. This
randomized clinical trial on 60 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 with neurogenic bladder,
systemic hypertension, obstructive uropathy and high grade vesicouretera are
excluded.Patients in Intervention group are administered omega-3 based on body weight in
divided doses in addition to antibiotic regimens and patients in control group received
antibiotic regimens without omega-3. Primary outcome is the development of renal scar by
doing DMSA renal scan on the 7th day of admission and four to six months after the
intervention and compared between groups.Also,measurement of urinary biomarker of acute
kidney injury (NGAL) three days after antibiotic or omega-3 administration for assessing of
subsequent scarring in both groups will be done . Secondary outcome is the incidence and
severity of renal scarring after pyelonephritis and response to treatment between two
groups.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02007889 -
L-carnitine on the Prevention of Renal Scarring in Acute Pyelonephritis
|
Phase 3 |