- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04571359
Spot Urine Oxalate to Creatinine Ratio and 24 Hours Urinary Oxalate
Relationship of Spot Urine Oxalate to Creatinine Ratio and 24 Hours Urinary Oxalate Excretion in Patients With Urolithiasis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A cross-sectional study was conducted at Section of Chemical Pathology, Department of Pathology and Laboratory Medicine, Aga Khan University, Karachi from 1st February to 31st December 2019. Adult patients with history of kidney stones presenting at the Clinical Laboratory for 24 hours urine oxalate estimation were included in the study. Debilitated or bed ridden patients and patients with renal failure or end stage renal disease, in whom urinary oxalate is no longer an indicator of disease status were excluded from the study. Study was approved by ethical review committee of Aga Khan University Hospital. Patients after informed consent, were guided to submit a spot urine sample. Clinical details were recorded on a structured questionnaire by the principal investigator.
24 hour urine samples were collected in a jar having thymol, which is routinely added to limit bacterial growth and hence guard against citrate degradation. Spot urine samples were collected in red top container without any added preservatives. The specimen were transported to the laboratory within the 12 hours of collection of 24 hour urinary specimen.
Volume of 24 hour urine was measured in liters. After mixing of the urinary sample to overcome effects of sedimentation, a 6 ml aliquot was made and HCl was added to avoid the precipitation of oxalate crystals in every sample. Specimen was stored at -20 C till further analysis.
Urinary oxalate was measured on Micro lab 300 using a kit based on oxalate oxidase principle by Trinity Biotech plc. Wick low, Ireland following standard operating procedures. Urinary creatinine was measured on ADVIA 1800 by Siemens, US using kinetic Jaffe reaction. Both normal and abnormal quality control materials were run with every batch of oxalate and creatinine analysis in urine to validate the results. In addition, external proficiency testing of urinary oxalate was conducted by College of American Pathologists (CAP).
The cut-offs for 24 hour oxalate excretion was 502 ųmol/24 hours for males and 353 ųmol/24 hours for females. The cut-offs for spot oxalate: creatinine ratio was 33 ųmol/mmol for males and 45 ųmol/mmol for females.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pakistan, Sindh
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Karachi, Pakistan, Sindh, Pakistan, 75800
- Syed bilal hashmi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with history of kidney stones.
- All patients investigated for 24 hour urinary oxalate excretion.
- Patients between 18 years to 60 years would be included.
- Both genders will be included.
Exclusion Criteria:
- Debilitated patients or bed ridden patients in whom proper and complete 24 hour urine collection will be troublesome.
- Patients with renal failure/end stage renal disease, in whom urinary oxalate is no longer an indicator of disease status.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relationship between 24 hour urinary oxalate excretion and spot urine oxalate to creatinine ratio
Time Frame: 1 year
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Relationship between 24 hour urinary oxalate excretion and spot urine oxalate to creatinine ratio to determine its clinical utility against the use of 24 hour urinary oxalate estimation which is the standard practice.
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Syed bilal hashmi, AKUH
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5084-Pat-ERC-17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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