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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.

Sponsored by Jörg Schefold · Observational

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

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).

02

Conditions studied

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

Keywords

  • AKI
03

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

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 informed consent
  • Age \< 18
  • Patients not speaking German or French.
04

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

05

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

06

Study locations

1 site
  • Inselspital
    Bern, 3010, Switzerland
07

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

08

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 ↗

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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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