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

Primary Purpose

Acute Pyelonephritis(APN)

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
L-carnitine
Sponsored by
Shahid Beheshti University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Pyelonephritis(APN)

Eligibility Criteria

1 Month - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Isfahan University of Medical Sciences,Alzahra HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

L-carnitine

Control

Arm Description

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

control group received just antibiotic regimens without L-carnitine

Outcomes

Primary Outcome Measures

Development of renal scar by doing DMSA renal scan

Secondary Outcome Measures

Severity of pyelonephritis and response to treatment.

Full Information

First Posted
September 21, 2013
Last Updated
December 5, 2013
Sponsor
Shahid Beheshti University
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1. Study Identification

Unique Protocol Identification Number
NCT02007889
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pyelonephritis(APN)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
L-carnitine
Arm Type
Active Comparator
Arm Description
50 mg/kg/day carnitine in divided 2-3 times/day (maximum 3 g/day) in addition to antibiotic regimens
Arm Title
Control
Arm Type
No Intervention
Arm Description
control group received just antibiotic regimens without L-carnitine
Intervention Type
Drug
Intervention Name(s)
L-carnitine
Intervention Description
50 mg/kg/day carnitine in divided 2-3 times/day (maximum 3 g/day) in addition to antibiotic regimens
Primary Outcome Measure Information:
Title
Development of renal scar by doing DMSA renal scan
Time Frame
Seven and six months after the intervention
Secondary Outcome Measure Information:
Title
Severity of pyelonephritis and response to treatment.
Time Frame
Six month after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Azadeh Eshraghi, Ph.D
Phone
009809133152584
Email
aepharm@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Golnaz Vaseghi, Ph.D pharmacology
Organizational Affiliation
Physiology Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alaleh Gheisari
Organizational Affiliation
Pediatric Nephrologist,Isfahan University, Isfahan, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nahid Aslani, Resident of pediatrics
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Azadeh Eshraghi, Clinical Pharmacist
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isfahan University of Medical Sciences,Alzahra Hospital
City
Isfahan
ZIP/Postal Code
0098
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azadeh Eshraghi, Ph.D
Phone
009809133152584
Email
aepharm@gmail.com

12. IPD Sharing Statement

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

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