Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03469765
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : September 7, 2018
Information provided by (Responsible Party):
Jörg Schefold, University Hospital Inselspital, Berne

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
Renal Failure Dialysis Aortic Surgery Biomarker Acute Kidney Injury Other: does not apply

Layout table for study information
Study Type : Observational
Estimated 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 : June 19, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Group/Cohort 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

Primary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
Urine, Blood

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03469765

Layout table for location contacts
Contact: Jan Waskowski, MD +41-31-632-2111
Contact: Joerg C Schefold, MD

Layout table for location information
Inselspital Recruiting
Bern, Switzerland, 3010
Contact: Joerg Schefold         
Sponsors and Collaborators
Jörg Schefold

Layout table for additonal information
Responsible Party: Jörg Schefold, Sponsor-investigator, University Hospital Inselspital, Berne Identifier: NCT03469765     History of Changes
Other Study ID Numbers: TIGER
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jörg Schefold, University Hospital Inselspital, Berne:

Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases