NCT03469765

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 19, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2019

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

March 9, 2018

Last Update Submit

September 23, 2019

Conditions

Renal FailureDialysisAortic SurgeryBiomarkerAcute Kidney Injury

Keywords

AKI

Outcome Measures

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.

    24 hours following ICU admission

Study Arms (1)

Group of patients after aortic surgery

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

Other: does not apply

Interventions

does not applyOTHER

biological sample taking: urine, blood

Group of patients after aortic surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with need for aortic operation/ repair

You may not qualify if:

  • Patients unable to give informed consent
  • Age \< 18
  • Patients not speaking German or French.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital

Bern, 3010, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 33411755DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine, Blood

MeSH Terms

Conditions

Renal InsufficiencyAcute Kidney Injury

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-investigator

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 19, 2018

Study Start

June 19, 2018

Primary Completion

September 23, 2019

Study Completion

September 23, 2019

Last Updated

September 24, 2019

Record last verified: 2019-09

Locations

CH(1)