Renal Insufficiency, AcuteNCT03311256
Determination of the "Tissue Transit Time" (TTT)
An observational study of Renal Insufficiency, Acute, run by University Hospital Tuebingen at 9 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Renal Insufficiency, Acute
- What is being tested?
- Tissue Transit Time
- How many people
- 119 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 23 Nov 2017to 24 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Term born infants <= 3 months of age with a unilateral, insolated hydronephrosis >= grade III (SFU)
Who may be able to join
- unilateral, isolated hydronephrosis >= grade III (SFU)
- age <= 3 months
Who cannot join
- associated malformation of the urogenital tract
- global kidney insufficiency proven by creatinine examination
- prematurity
- no informed consent
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany8 sites
Kinderchirurgische Klinik
Augsburg, 86156
Klinik für Kinderchirurgie und Kinderurologie
Bremen, 28205
Klinik für Kinderchirurgie und Kinderurologie
Dortmund, 44137
Kinderchirurgische Klinik
Karlsruhe, 76133
Zentrum für Kinder- und Jugendurologie
Mannheim, 68167
Klinik für Kinderchirurgie
Marburg, 35043
Cnopf'sche Kinderklinik
Nuremberg, 90419
Klinik für Kinder- und Jugendmedzin
Tübingen, 72076
Switzerland1 site
Kinderchiurgische Klinik, Luzerner Kantonsspital
Lucerne, 6000
About this study
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
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
Read the 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
- Conditions
- Renal Insufficiency, Acute
- Being tested
- Tissue Transit Time
- Keywords
- Tissue Transit Time
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Transit TimeDiagnostic test
Determination of Tissue Transit Time as a prognostic and diagnostic factor
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 to 6 months
Secondary outcomes (3)
Examination of ultrasound findings
Relationship between ultrasound findings and the development of the differential renal function
Measured: 3 to 6 months
Examination of renal drainage
Relationship between initial quality of renal drainage and the development of the differential renal function
Measured: 3 to 6 months
Examination of initial differential renal function
Relationship between initial differential renal function and the development of the differential renal function
Measured: 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start23 Nov 2017
- Primary completion30 Jun 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, AcuteStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Luithle, MD, Principal investigator, Universtiätsklinikum Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311256
- Sponsor's protocol ID
- TTT
- Status last verified
- Nov 2020
- First submitted
- 11 Oct 2017
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37718234
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03311256
- Acronym / sponsor ID
- TTT
- Conditions
- Renal Insufficiency, Acute
- Keywords
- Tissue Transit Time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Term born infants <= 3 months of age with a unilateral, insolated hydronephrosis >= grade III (SFU)
Key inclusion criteria (2 listed)
- unilateral, isolated hydronephrosis >= grade III (SFU)
- age <= 3 months
Key exclusion criteria (4 listed)
- associated malformation of the urogenital tract
- global kidney insufficiency proven by creatinine examination
- prematurity
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue Transit TimeDetermination of Tissue Transit Time as a prognostic and diagnostic factor | Diagnostic test | – |
Primary outcome
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
3 secondary outcomes
Examination of ultrasound findings
Time frame: 3 to 6 months
Examination of renal drainage
Time frame: 3 to 6 months
Examination of initial differential renal function
Time frame: 3 to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Derived from this study: PubMed 37718234Luithle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Luithle, MD principal investigator
Universtiätsklinikum Tübingen
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insufficiency, Acute, run by University Hospital Tuebingen at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity (time frame: 3 to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03311256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.