HematuriaNCT06504771
Clinical and Laboratory Patterns of Pediatric Gross Hematuria
An observational study of Hematuria, run by Sohag University at 1 site in Egypt.
Trial summary
Study the demographic, clinical, laboratory and etiological profile of children with gross hematuria and trace the outcome of these patients for at least 3 months follow up. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Hematuria
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to Feb 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 16 years
- All sexes
- Child
Study population: patients with gross hematuria at The pediatric department and pediatric nephrology outpatient clinic at Sohag University hospital, Sohag, Egypt
Who may be able to join
- lnvestigators will include all patients complaining of gross hematuria between the ages of 1 month up to 16 years.
Who cannot join
- Children with external perineal or genital region bleeding which may falsely cause presence of blood in urine samples.
- Patients whose legal guardians will refuse participation in the study.
- Patients with follow up for less than 3 months.
Trial locations and contacts
1 site in 1 country.
Rania G Mostafa, Lecturer contact
Egypt1 site
Faculty of Medicine,Sohag University
Sohag
haya M AbdelHameed, Master, 01065860928
About this study
Official title: Clinical and Laboratory Patterns of Pediatric Gross Hematuria in Sohag University Hospital
Study the demographic, clinical, laboratory and etiological profile of children with gross hematuria and trace the outcome of these patients for at least 3 months follow up.
Read the detailed description
Gross hematuria is a scary but common medical problem in children. This condition is considered one of the most important manifestations of kidney and urinary tract diseases. When colour of urine with blood is reddish, brown or dark or cola coloured, the condition is called as macroscopic (gross) hematuria. However, blood in urine may not always be visible to the naked eye, when it is called as microscopic hematuria.
This condition can be transient, intermittent or persistent and it may be symptomatic or asymptomatic. Hematuria originating from glomerulus is almost never bright red but usually brown, tea coloured or cola coloured. In contrary, hematuria originating from the lower urinary tract is usually pink or red in colour.
Pigments and other compounds in certain foods (including beets, berries, and food colourings) and drugs (sulfonamides, rifampicin, ibuprofen, salicylates, phenothiazines, metronidazole, phenolphthalein, chloroquine, deferoxamine, etc.) can change the colour of urine that is called false hematuria.
The causes of hematuria are very diverse, ranging from simple urinary tract infections with rapid recovery to mechanical trauma and severe glomerulonephritis with rapid decline in kidney function, it is essential to recognize the underlying disease and treat it accordingly.
The causes of gross hematuria may be categorized to whether the hematuria is glomerular or non-glomerular in origin. This distinction can be determined by microscopic examination of the urine to detect dysmorphic or monomorphic red blood cells in glomerular and non-glomerular hematuria, respectively. Although glomerular diseases are nearly always associated with some degree of hematuria, gross hematuria as a presenting manifestation is more commonly encountered with acute poststreptococcal glomerulonephritis, lupus nephritis and IgA nephropathy. Non-glomerular hematuria is most often associated with renal stones, tumours, idiopathic hypercalciuria, bacterial or viral urinary tract infection, urolithiasis and structural anomalies of the urinary tract.
It is essential to establish the cause and origin of hematuria in each case through proper history, clinical features and investigations including laboratory, radiological studies and/or percutaneous renal biopsy in some cases. But at the same time, it is important that the pediatrician is aware what any of such procedures might be helpful in establishing a proper diagnosis.
- Conditions
- Hematuria
- Keywords
- Gross hematuria
- Medical subject headings
- Hematuria
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the creatinine level of the studied cases
follow up of creatinine level in mg/dl of the studied cases
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematuriaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haya Mahmoud Abdelhameed, Sohag University
- Investigators
- Abdelrahim Sadek, Professor, Study director, Faculty of Medicine, Sohag university, EgyptGhada A Abd-Elrehim, Lecturer, Study director, Faculty of Medicine, Sohag university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504771
- Sponsor's protocol ID
- Soh-Med-24-06-13MS
- Status last verified
- Jul 2024
- First submitted
- 5 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Laboratory Patterns of Pediatric Gross Hematuria in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06504771
- Acronym / sponsor ID
- Soh-Med-24-06-13MS
- Conditions
- Hematuria
- Keywords
- Gross hematuria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study the demographic, clinical, laboratory and etiological profile of children with gross hematuria and trace the outcome of these patients for at least 3 months follow up.
Detailed description
Gross hematuria is a scary but common medical problem in children. This condition is considered one of the most important manifestations of kidney and urinary tract diseases. When colour of urine with blood is reddish, brown or dark or cola coloured, the condition is called as macroscopic (gross) hematuria. However, blood in urine may not always be visible to the naked eye, when it is called as microscopic hematuria.
This condition can be transient, intermittent or persistent and it may be symptomatic or asymptomatic. Hematuria originating from glomerulus is almost never bright red but usually brown, tea coloured or cola coloured. In contrary, hematuria originating from the lower urinary tract is usually pink or red in colour.
Pigments and other compounds in certain foods (including beets, berries, and food colourings) and drugs (sulfonamides, rifampicin, ibuprofen, salicylates, phenothiazines, metronidazole, phenolphthalein, chloroquine, deferoxamine, etc.) can change the colour of urine that is called false hematuria.
The causes of hematuria are very diverse, ranging from simple urinary tract infections with rapid recovery to mechanical trauma and severe glomerulonephritis with rapid decline in kidney function, it is essential to recognize the underlying disease and treat it accordingly.
The causes of gross hematuria may be categorized to whether the hematuria is glomerular or non-glomerular in origin. This distinction can be determined by microscopic examination of the urine to detect dysmorphic or monomorphic red blood cells in glomerular and non-glomerular hematuria, respectively. Although glomerular diseases are nearly always associated with some degree of hematuria, gross hematuria as a presenting manifestation is more commonly encountered with acute poststreptococcal glomerulonephritis, lupus nephritis and IgA nephropathy. Non-glomerular hematuria is most often associated with renal stones, tumours, idiopathic hypercalciuria, bacterial or viral urinary tract infection, urolithiasis and structural anomalies of the urinary tract.
It is essential to establish the cause and origin of hematuria in each case through proper history, clinical features and investigations including laboratory, radiological studies and/or percutaneous renal biopsy in some cases. But at the same time, it is important that the pediatrician is aware what any of such procedures might be helpful in establishing a proper diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- patients with gross hematuria at The pediatric department and pediatric nephrology outpatient clinic at Sohag University hospital, Sohag, Egypt
Key inclusion criteria (1 listed)
- lnvestigators will include all patients complaining of gross hematuria between the ages of 1 month up to 16 years.
Key exclusion criteria (3 listed)
- Children with external perineal or genital region bleeding which may falsely cause presence of blood in urine samples.
- Patients whose legal guardians will refuse participation in the study.
- Patients with follow up for less than 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Investigate the creatinine level of the studied cases
Time frame: three months
follow up of creatinine level in mg/dl of the studied cases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Hematuria - Cause Not Known
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rania G Mostafa, Lecturer contact
Abdelrahim Sadek, Professor study director
Faculty of Medicine, Sohag university, Egypt
Ghada A Abd-Elrehim, Lecturer study director
Faculty of Medicine, Sohag university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematuria, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haya M AbdelHameed, Resident (01065860928, haya011222@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate the creatinine level of the studied cases (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.