Determination of the "Tissue Transit Time" (TTT)

Renal Insufficiency, Acute Clinical Trial

Official title:

Determination of the "Tissue Transit Time" (TTT) in the MAG3-Tc99 Diuretic Renogram for Risk Stratification of Infants With Ureteropelvic Junction Obstruction - a Multicentric Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311256
• Other study ID #: TTT
• Status: Completed
• Start date: November 23, 2017
• Est. completion date: November 24, 2021

Study information

• Verified date: November 2020
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Determination of Tissue Transit Time (TTT) as a parameter with high prognostic value to predict the functional course of the differential renal function and the development of the differential renal function after pyeloplasty

Description:

The ureteropelvic junction obstruction occurs in around 13% of children with antenatally diagnosed hydronephrosis. It remains a controversial topic what prognostic factors may be predictive for deterioration of the differential renal function.

The tissue transit time (TTT) in the 99mTc- MAG3 diuretic renogram seems to be a predictive factor for the deterioration of the differential renal function in these patients. We therefore analyze the tissue transit time in the 99mTc- MAG3 diuretic renogram in a prospective multicenter observational study to determine it as a prognostic and diagnostic factor. Aim of the study is to differentiate which children could be treated conservatively and which will benefit from operative pyeloplasty

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: November 24, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

Inclusion Criteria:

• unilateral, isolated hydronephrosis >= grade III (SFU)

• age <= 3 months

Exclusion Criteria:

• associated malformation of the urogenital tract

• global kidney insufficiency proven by creatinine examination

• prematurity

• no informed consent

Related Conditions & MeSH terms

• Acute Kidney Injury
• Renal Insufficiency
• Renal Insufficiency, Acute

Intervention

Diagnostic Test:
• Tissue Transit Time
Determination of Tissue Transit Time as a prognostic and diagnostic factor

Locations

Country	Name	City	State
Germany	Kinderchirurgische Klinik	Augsburg
Germany	Klinik für Kinderchirurgie und Kinderurologie	Bremen
Germany	Klinik für Kinderchirurgie und Kinderurologie	Dortmund
Germany	Kinderchirurgische Klinik	Karlsruhe
Germany	Zentrum für Kinder- und Jugendurologie	Mannheim
Germany	Klinik für Kinderchirurgie	Marburg
Germany	Cnopf'sche Kinderklinik	Nürnberg
Germany	Klinik für Kinder- und Jugendmedzin	Tübingen
Switzerland	Kinderchiurgische Klinik, Luzerner Kantonsspital	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity	Estimation of Sensitivity and Specificity of a delayed tissue transit time as a diagnostic factor concerning worsening of the differential renal function in patients with congenital ureteropelvic junction obstruction	3 to 6 months
Secondary	Examination of ultrasound findings	Relationship between ultrasound findings and the development of the differential renal function	3 to 6 months
Secondary	Examination of renal drainage	Relationship between initial quality of renal drainage and the development of the differential renal function	3 to 6 months
Secondary	Examination of initial differential renal function	Relationship between initial differential renal function and the development of the differential renal function	3 to 6 months