ClinicalTrials.gg
CompletedNCT03469765TIGERUpdated Sep 24, 2019

(TIMP-2)x(IGFPB7) to Predict Acute Kidney Injury (AKI) in Aortic Surgery

An observational study in Renal Failure, Dialysis and Aortic Surgery, sponsored by Jörg Schefold. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-24.

Primary conditionAcute Kidney InjuryRegistry: Renal InsufficiencyReclassifiedWhy we changed it
Registry
Renal Insufficiency — the first condition term the registry derived for this study.
ClinicalTrials.gg
Acute Kidney Injury
Why
  1. The study's listed conditions name Acute Kidney Injury, a narrower term within Renal Insufficiency.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Jörg Schefold · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 26 studies in Acute Kidney Injury with a site in Switzerland — 2 open to participants now, 3 under way, none of them phase 3. Acute Kidney Injury · Switzerland.

Enrollment
8th of 11
100 · median 119
Started
2018
the only one that year
Observational
12 of 26
2 open now
Registered
18th of 26
by date
Lead sponsor
1 of 26
Jörg Schefold

Among the 26 studies in Acute Kidney Injury with a site in Switzerland, this one is the 8th largest by enrollment of the 11 observational ones that give a count, is the only one that started in 2018, is one of 12 observational ones, and was the 18th registered.

Acute Kidney Injury

1,691 studies on the registry are indexed under Acute Kidney Injury; 394 are open to participants now.

Browse Acute Kidney Injury studies →

Open to participants now

2 of the 26 studies in Acute Kidney Injury with a site in Switzerland are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 230 Acute Kidney Injury studies recruiting now, 161 (70%) set no upper age limit and 36 (16%) stop at 75 or younger; 22 take children under 18; 25 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 26 studies in Acute Kidney Injury with a site in Switzerland, or all of them as a file.
02

Study summary

New biomarkers that predict the development of renal dysfunction in patients with aortic surgery are urgently needed. The investigators investigate whether urinary (TIMP-2)x(IGFBP7) predicts postoperative Acute Kidney Injury and/or need for Renal Replacement Therapy (RRT) in patients after aortic surgery (including EVAR).

03

Conditions studied

  • Renal Failure
  • Dialysis
  • Aortic Surgery
  • Biomarker
  • Acute Kidney Injury

Browse trials for

Keywords

  • AKI
04

In context

Acute Kidney Injury Reclassified

1,691 studies on the registry are indexed under Acute Kidney Injury; 394 are open to participants now.

This study's enrollment of 100 is below the median of 160 across 814 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Jörg Schefold is the lead sponsor of 2 studies on the registry; none are open to participants now.

Compared within Acute Kidney Injury, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Renal Insufficiency. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with need for aortic operation/ repair

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients in need of emergency or elective abdominal aortic surgery (infra- or suprarenal clamping or EVAR) are eligible for study inclusion.

Exclusion criteria

Exclusion Criteria:

  • Patients unable to give
  • Age \< 18
  • Patients not speaking German or French.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

06

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Group of patients after aortic surgery

    with subanalysis of patients with/without supra-/infrarenal surgery

    Other: does not apply

Interventions

  • Otherdoes not apply

    biological sample taking: urine, blood

07

What researchers measure

Primary outcomes

  1. Statistically significant difference in mean total (TIMP-2)x(IGFBP7) values of patients with/ without AKI (as defined along Kidney Disease Initiative for Improvement of global outcomes (KDIGO) definitions: stages 1-3) at the first postoperative day.

    Time frame: 24 hours following ICU admission

08

Study locations

1 site
  • Inselspital
    Bern, 3010, Switzerland
09

References and documents

Publications

  • Waskowski J, Pfortmueller CA, Schenk N, Buehlmann R, Schmidli J, Erdoes G, Schefold JC. (TIMP2) x (IGFBP7) as early renal biomarker for the prediction of acute kidney injury in aortic surgery (TIGER). A single center observational study. PLoS One. 2021 Jan 7;16(1):e0244658. doi: 10.1371/journal.pone.0244658. eCollection 2021. Erratum In: PLoS One. 2021 Oct 29;16(10):e0259567. doi: 10.1371/journal.pone.0259567. PubMed 33411755 ↗

Individual participant data

Plan to share: Undecided

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in Sep 2019, 15 months.

Of 349 non-industry observational studies under Acute Kidney Injury, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's 15 months is below that.

Counting every sponsor, half of 364 studies reached it within 24 months; a quarter within 12 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 9, 2018
First posted
Mar 19, 2018
StartActual
Jun 19, 2018
Primary completionActual
Sep 23, 2019
CompletionActual
Sep 23, 2019
Last update
Sep 24, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03469765
Lead sponsor
Jörg Schefold
Responsible party
Jörg Schefold (Sponsor-investigator, Insel Gruppe AG, University Hospital Bern) — Sponsor-investigator
First posted
Mar 19, 2018
Start date
Jun 19, 2018
Primary completion
Sep 23, 2019
Completion
Sep 23, 2019
Last update
Sep 24, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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