Ignite Creation Date:
2024-05-06 @ 3:04 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02192580
Status:
UNKNOWN
Last Update Posted:
2014-07-17
First Post:
2014-07-13
Brief Title:
Oral Omega-3 for Reduction of Kidney Scar Due to Pyelonephritis in Children
Sponsor:
Shahid Beheshti University
Organization:
Shahid Beheshti University
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2014-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Urinary tract infections UTI are a common and important clinical problem in childhoodUpper urinary tract infections ie acute pyelonephritis may lead to renal scarring hypertension and end-stage renal diseasePathogenesis 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 pyelonephritiswe 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 inflammationThis 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 conductedChildren 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 excludedPatients 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 groupsAlsomeasurement 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
Several studies show that omega-3 alleviated oxidative stress and inflammationThis 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 conductedChildren 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 excludedPatients 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 groupsAlsomeasurement 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None