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L-carnitine on the Prevention of Renal Scarring in Acute Pyelonephritis

NCT ID: NCT02007889

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Pyelonephritis(APN)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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L-carnitine

50 mg/kg/day carnitine in divided 2-3 times/day (maximum 3 g/day) in addition to antibiotic regimens

Group Type ACTIVE_COMPARATOR

L-carnitine

Intervention Type DRUG

50 mg/kg/day carnitine in divided 2-3 times/day (maximum 3 g/day) in addition to antibiotic regimens

Control

control group received just antibiotic regimens without L-carnitine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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L-carnitine

50 mg/kg/day carnitine in divided 2-3 times/day (maximum 3 g/day) in addition to antibiotic regimens

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University

OTHER

Sponsor Role lead

Responsible Party

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Azadeh Eshraghi

Clinical Pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Golnaz Vaseghi, Ph.D pharmacology

Role: PRINCIPAL_INVESTIGATOR

Physiology Research Center

Alaleh Gheisari

Role: PRINCIPAL_INVESTIGATOR

Pediatric Nephrologist,Isfahan University, Isfahan, Iran

Nahid Aslani, Resident of pediatrics

Role: PRINCIPAL_INVESTIGATOR

Isfahan University of Medical Sciences

Azadeh Eshraghi, Clinical Pharmacist

Role: PRINCIPAL_INVESTIGATOR

Shahid Beheshti University of Medical Sciences

Locations

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Isfahan University of Medical Sciences,Alzahra Hospital

Isfahan, Isfahan, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Azadeh Eshraghi, Ph.D

Role: CONTACT

Phone: 009809133152584

Email: [email protected]

Facility Contacts

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Azadeh Eshraghi, Ph.D

Role: primary

Other Identifiers

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ShahidBU

Identifier Type: -

Identifier Source: org_study_id