Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Determination of the "Tissue Transit Time" (TTT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date October 11, 2017
First Posted Date October 17, 2017
Last Update Posted Date November 10, 2020
Actual Study Start Date November 23, 2017
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 19, 2017)
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
Original Primary Outcome Measures
 (submitted: October 11, 2017)
Sensitivity and Specifity [ Time Frame: 3 to 6 months ]
Estimation of Sensitivity and Specifity of a delayed tissue transit time as a diagnostic factor concerning worsening of the differential renal function in patients with congenital ureteropelvic junction obstruction
Change History
Current Secondary Outcome Measures
 (submitted: October 19, 2017)
  • Examination of ultrasound findings [ Time Frame: 3 to 6 months ]
    Relationship between ultrasound findings and the development of the differential renal function
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: October 11, 2017)
  • Examination of ultrasound findings [ Time Frame: 3 to 6 months ]
    Relationsship between ultrasound findings and the development of the differential renal function
  • Examination of renal drainage [ Time Frame: 3 to 6 months ]
    Relationsship between initial quality of renal drainage and the development of the differential renal function
  • Examination of initial differential renal function [ Time Frame: 3 to 6 months ]
    Relationsship between initial differential renal function and the development of the differential renal function
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Determination of the "Tissue Transit Time" (TTT)
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
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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Term born infants <= 3 months of age with a unilateral, insolated hydronephrosis >= grade III (SFU)
Condition Renal Insufficiency, Acute
Intervention Diagnostic Test: Tissue Transit Time
Determination of Tissue Transit Time as a prognostic and diagnostic factor
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: November 9, 2020)
119
Original Estimated Enrollment
 (submitted: October 11, 2017)
154
Estimated Study Completion Date April 30, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 3 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03311256
Other Study ID Numbers TTT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital Tuebingen
Study Sponsor University Hospital Tuebingen
Collaborators Not Provided
Investigators
Principal Investigator: Tobias Luithle, MD Universtiätsklinikum Tübingen
PRS Account University Hospital Tuebingen
Verification Date November 2020