NCT03311256

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 23, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2021

Completed
Last Updated

May 9, 2022

Status Verified

November 1, 2020

Enrollment Period

3.6 years

First QC Date

October 11, 2017

Last Update Submit

May 6, 2022

Conditions

Keywords

Tissue Transit Time

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Examination of ultrasound findings

    3 to 6 months

  • Examination of renal drainage

    3 to 6 months

  • Examination of initial differential renal function

    3 to 6 months

Interventions

Tissue Transit TimeDIAGNOSTIC_TEST

Determination of Tissue Transit Time as a prognostic and diagnostic factor

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Term born infants \<= 3 months of age with a unilateral, insolated hydronephrosis \>= grade III (SFU)

You may qualify if:

  • unilateral, isolated hydronephrosis \>= grade III (SFU)
  • age \<= 3 months

You may not qualify if:

  • associated malformation of the urogenital tract
  • global kidney insufficiency proven by creatinine examination
  • prematurity
  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Kinderchirurgische Klinik

Augsburg, 86156, Germany

Location

Klinik für Kinderchirurgie und Kinderurologie

Bremen, 28205, Germany

Location

Klinik für Kinderchirurgie und Kinderurologie

Dortmund, 44137, Germany

Location

Kinderchirurgische Klinik

Karlsruhe, 76133, Germany

Location

Zentrum für Kinder- und Jugendurologie

Mannheim, 68167, Germany

Location

Klinik für Kinderchirurgie

Marburg, 35043, Germany

Location

Cnopf'sche Kinderklinik

Nuremberg, 90419, Germany

Location

Klinik für Kinder- und Jugendmedzin

Tübingen, 72076, Germany

Location

Kinderchiurgische Klinik, Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

Related Publications (1)

  • Luithle T, Obermayr F, Dittmann H, Engel C, Etzler A, Kosch F, Menke IT, Schafer M, Schuster T, Younsi N, Fuchs J. Determination of tissue tracer transit of Technetium-99m-mercaptoacetyltriglycine diuretic renography in infants with suspected ureteropelvic junction obstruction - A multicenter prospective observational study. J Pediatr Urol. 2023 Dec;19(6):780.e1-780.e7. doi: 10.1016/j.jpurol.2023.08.029. Epub 2023 Sep 1.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Tobias Luithle, MD

    Universtiätsklinikum Tübingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2017

First Posted

October 17, 2017

Study Start

November 23, 2017

Primary Completion

June 30, 2021

Study Completion

November 24, 2021

Last Updated

May 9, 2022

Record last verified: 2020-11

Locations