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

Sponsor

Jörg Schefold (Other)

Overall Status

Completed

CT.gov ID

NCT03469765

Collaborator

(none)

100

Enrollment

Location

15.1

Actual Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Renal Failure Dialysis Aortic Surgery Biomarker Acute Kidney Injury	Other: does not apply

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

(TIMP-2)x(IGFPB7) as Early Renal Biomarker for the Prediction of Acute Kidney Injury in Aortic Surgery - an Observational Study (TIGER)

Actual Study Start Date :

Jun 19, 2018

Actual Primary Completion Date :

Sep 23, 2019

Actual Study Completion Date :

Sep 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Group of patients after aortic surgery with subanalysis of patients with/without supra-/infrarenal surgery	Other: does not apply biological sample taking: urine, blood

Arm

Intervention/Treatment

Group of patients after aortic surgery

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

Other: does not apply

biological sample taking: urine, blood

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inselspital	Bern		Switzerland	3010

Sponsors and Collaborators

Jörg Schefold

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jörg Schefold, Sponsor-investigator, University Hospital Inselspital, Berne

ClinicalTrials.gov Identifier:

NCT03469765

Other Study ID Numbers:

TIGER

First Posted:

Mar 19, 2018

Last Update Posted:

Sep 24, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jörg Schefold, Sponsor-investigator, University Hospital Inselspital, Berne

AKI

Additional relevant MeSH terms:

Acute Kidney Injury

Wounds and Injuries

Study Results

No Results Posted as of Sep 24, 2019