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Completed

NCT Number: NCT03311256

Determination of the "Tissue Transit Time" (TTT)

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

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Key information

Conditions

Renal Insufficiency, Acute Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Kinderchirurgische Klinik, Augsburg, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tissue Transit Time

Diagnostic Test

Determination of Tissue Transit Time as a prognostic and diagnostic factor

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 17, 2017
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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