CTT on Renogram as an Early Marker of Significant Obstruction in Uretero-pelvic Junction Syndrome

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE LA RÉUNION · Jun 21, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a new way to detect significant blockages in a condition called ureteropelvic junction obstruction (UPJO), which can affect the kidneys. The researchers are particularly interested in using a test called a diuretic renogram to measure how quickly a substance moves through the kidneys. This method could help identify serious problems early on in infants who were diagnosed with UPJO before birth.

To be eligible for this trial, infants must be between 4 and 8 weeks old and have been diagnosed with a unilateral (one-sided) UPJO, confirmed by an ultrasound. It's important that their legal guardians agree to their participation. During the study, parents can expect their infants to undergo specific tests to measure kidney function and monitor for any issues. This trial aims to improve early detection and management of UPJO, potentially leading to better outcomes for affected infants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Infants:
• • Aged of 4 to 8 weeks of life
• • Presenting an ureteropelvic junction obstruction (UPJO) detected before birth by ultrasound
• • Presenting an UPJO, defined by an Antero-Posterior Renal Pelvic Diameter greater or equal to 15 mm, confirmed by ultrasound post-natally between the 1st and 15th day of life
• • Presenting a unilateral UPJO
• • whose legal representatives have provided a signed free and informed written consent for their infant's participation
• • whose at least one of his legal representative is affiliated to national social security
• Exclusion Criteria:
• Infants presenting:
• • A bilateral UPJO
• • An ureteral dilatation
• • An associated contralateral uropathy
• • A solitary kidney
• • A renal insufficiency
• • Severe associated disabilities ( ie polymalformation syndromes)
• • A concomitant participation in another trial
• • A contraindication to furosemide (acute renal insufficiency, hepatic encephalopathy, hypovolemia or dehydration, severe hypokalemia, severe hyponatremia)
• • A contraindication to the radionuclide marker (hypersensitivity to the active substance or to excipients)