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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

Tracking Information
First Submitted Date March 9, 2018
First Posted Date March 19, 2018
Last Update Posted Date September 7, 2018
Actual Study Start Date June 19, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 16, 2018)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03469765 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title (TIMP-2)x(IGFPB7) to Predict Acute Kidney Injury (AKI) in Aortic Surgery
Official Title (TIMP-2)x(IGFPB7) as Early Renal Biomarker for the Prediction of Acute Kidney Injury in Aortic Surgery - an Observational Study (TIGER)
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Urine, Blood
Sampling Method Probability Sample
Study Population Patients with need for aortic operation/ repair
Condition
  • Renal Failure
  • Dialysis
  • Aortic Surgery
  • Biomarker
  • Acute Kidney Injury
Intervention Other: does not apply
biological sample taking: urine, blood
Study Groups/Cohorts Group of patients after aortic surgery
with subanalysis of patients with/without supra-/infrarenal surgery
Intervention: Other: does not apply
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 16, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jan Waskowski, MD +41-31-632-2111 jan.waskowski@insel.ch
Contact: Joerg C Schefold, MD joerg.schefold@insel.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03469765
Other Study ID Numbers TIGER
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Jörg Schefold, University Hospital Inselspital, Berne
Study Sponsor Jörg Schefold
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital Inselspital, Berne
Verification Date September 2018