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Determination of the "Tissue Transit Time" (TTT)

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ClinicalTrials.gov Identifier: NCT03311256
Recruitment Status : Active, not recruiting
First Posted : October 17, 2017
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

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
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

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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 : November 23, 2017
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

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


Primary Outcome Measures :
  1. Sensitivity and Specificity [ Time Frame: 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 :
  1. Examination of ultrasound findings [ Time Frame: 3 to 6 months ]
    Relationship between ultrasound findings and the development of the differential renal function

  2. Examination of renal drainage [ Time Frame: 3 to 6 months ]
    Relationship between initial quality of renal drainage and the development of the differential renal function

  3. Examination of initial differential renal function [ Time Frame: 3 to 6 months ]
    Relationship between initial differential renal function and the development of the differential renal function



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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Term born infants <= 3 months of age with a unilateral, insolated hydronephrosis >= grade III (SFU)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311256


Locations
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Germany
Kinderchirurgische Klinik
Augsburg, Germany, 86156
Klinik für Kinderchirurgie und Kinderurologie
Bremen, Germany, 28205
Klinik für Kinderchirurgie und Kinderurologie
Dortmund, Germany, 44137
Kinderchirurgische Klinik
Karlsruhe, Germany, 76133
Zentrum für Kinder- und Jugendurologie
Mannheim, Germany, 68167
Klinik für Kinderchirurgie
Marburg, Germany, 35043
Cnopf'sche Kinderklinik
Nürnberg, Germany, 90419
Klinik für Kinder- und Jugendmedzin
Tübingen, Germany, 72076
Switzerland
Kinderchiurgische Klinik, Luzerner Kantonsspital
Luzern, Switzerland, 6000
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Tobias Luithle, MD Universtiätsklinikum Tübingen
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03311256    
Other Study ID Numbers: TTT
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Tuebingen:
Tissue Transit Time
Additional relevant MeSH terms:
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Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases