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

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ClinicalTrials.gov Identifier: NCT03469765
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : September 7, 2018
Sponsor:
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

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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


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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03469765


Contacts
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Contact: Jan Waskowski, MD +41-31-632-2111 jan.waskowski@insel.ch
Contact: Joerg C Schefold, MD joerg.schefold@insel.ch

Locations
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Switzerland
Inselspital Recruiting
Bern, Switzerland, 3010
Contact: Joerg Schefold         
Sponsors and Collaborators
Jörg Schefold

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Responsible Party: Jörg Schefold, Sponsor-investigator, University Hospital Inselspital, Berne
ClinicalTrials.gov 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

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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:
AKI

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