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HematuriaNCT06504771

Clinical and Laboratory Patterns of Pediatric Gross Hematuria

An observational study of Hematuria, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Haya M AbdelHameed, Resident contact

01065860928

haya011222@med.sohag.edu.eg

Rania G Mostafa, Lecturer contact

Egypt1 site
  • Faculty of Medicine,Sohag University

    Sohag

    haya M AbdelHameed, Master, 01065860928

Other trials in Egypt

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.

  1. 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.

  1. First posted17 Jul 2024
  2. Study start1 Aug 2024 (estimated)
  3. Primary completion1 Nov 2024 (estimated)
  4. Study completionFeb 2025 (estimated)

Resources

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
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

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.

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