Clinical trial NCT02007889: L-carnitine on the Prevention of Renal Scarring in Acute Pyelonephritis
Official title: The Effect of L-carnitine on the Prevention of Renal Scarring in Children With Acute Pyelonephritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Pyelonephritis(APN)
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 78
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* neurogenic bladder,
* systemic hypertension,
* obstructive uropathy

Primary outcomes:
measure: Development of renal scar by doing DMSA renal scan
timeFrame: Seven and six months after the intervention
Secondary outcomes:
measure: Severity of pyelonephritis and response to treatment.
timeFrame: Six month after intervention
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan University of Medical Sciences,Alzahra Hospital
Study officials:
affiliation: Physiology Research Center
name: Golnaz Vaseghi, Ph.D pharmacology
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Nephrologist,Isfahan University, Isfahan, Iran
name: Alaleh Gheisari
role: PRINCIPAL_INVESTIGATOR
affiliation: Isfahan University of Medical Sciences
name: Nahid Aslani, Resident of pediatrics
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Azadeh Eshraghi, Clinical Pharmacist
role: PRINCIPAL_INVESTIGATOR
References: