Determination of the "Tissue Transit Time" (TTT)

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Completed

CT.gov ID

NCT03311256

Collaborator

(none)

119

Enrollment

Locations

Actual Duration (Months)

13.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency, Acute	Diagnostic Test: Tissue Transit Time

Detailed 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

Study Design

Study Type:

Observational

Actual Enrollment :

119 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Nov 23, 2017

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Nov 24, 2021

Outcome Measures

Primary Outcome Measures

Sensitivity and Specificity [3 to 6 months]
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

Secondary Outcome Measures

Examination of ultrasound findings [3 to 6 months]
Relationship between ultrasound findings and the development of the differential renal function
Examination of renal drainage [3 to 6 months]
Relationship between initial quality of renal drainage and the development of the differential renal function
Examination of initial differential renal function [3 to 6 months]
Relationship between initial differential renal function and the development of the differential renal function

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 3 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Kinderchirurgische Klinik	Augsburg	Germany	86156
2	Klinik für Kinderchirurgie und Kinderurologie	Bremen	Germany	28205
3	Klinik für Kinderchirurgie und Kinderurologie	Dortmund	Germany	44137
4	Kinderchirurgische Klinik	Karlsruhe	Germany	76133
5	Zentrum für Kinder- und Jugendurologie	Mannheim	Germany	68167
6	Klinik für Kinderchirurgie	Marburg	Germany	35043
7	Cnopf'sche Kinderklinik	Nürnberg	Germany	90419
8	Klinik für Kinder- und Jugendmedzin	Tübingen	Germany	72076
9	Kinderchiurgische Klinik, Luzerner Kantonsspital	Luzern	Switzerland	6000

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator: Tobias Luithle, MD, Universtiätsklinikum Tübingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Tuebingen

ClinicalTrials.gov Identifier:

NCT03311256

Other Study ID Numbers:

First Posted:

Oct 17, 2017

Last Update Posted:

May 9, 2022

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital Tuebingen

Tissue Transit Time

Additional relevant MeSH terms:

Renal Insufficiency

Acute Kidney Injury

Study Results

No Results Posted as of May 9, 2022