Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 52 for:    TIMP2

RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery.

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02325726
Recruitment Status : Completed
First Posted : December 25, 2014
Last Update Posted : November 2, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:

Postoperative acute renal failure is a frequent complication after cardiac surgery. The current practice cannot predict Acute Kidney Injuries (AKI) early enough to reduce a significant kidney assault and prevent an organic dysfunction leading to cortical tubular necrosis.

Several recent studies in cardiac surgery have shown that, both sonographic criteria, such as the Renal Resistive Index (IRR) and urinary biomarkers can predict AKI promptly. These urinary biomarkers are the 'tissue inhibitor of metalloproteinases' (TIMP-2) and the 'insulin-like growth factor binding protein' (IGFBP7). These two proteins are sought noninvasively, directly in the urine, within the same test called 'NephroCheckTM'. These markers, ultrasonographic and biologic, have the advantage of being easy to perform, accessible and seem to have both high sensitivity and specificity to predict AKI promptly after cardiac surgery. Thus, the IRR and the NephroCheckTM test could become essential tests to guide clinicians in determining rapidly whether a patient will develop AKI. However, so far, no study has compared these markers yet.

Therefore, the aim of this prospective observational study will be to compare the effectiveness of the IRR with the NephroCheckTM to predict AKI promptly after cardiac surgery. The secondary outcome will be to determine the threshold of these markers from which patients will be likely to develop AKI


Condition or disease Intervention/treatment
Cardiac Surgery Extracorporeal Circulation Nephrocheck Renal Failure Procedure: Renal Resistive Index compared with NephroCheckTM

Layout table for study information
Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Renal Resistive Index Compared With NephroCheckTM to Predict Postoperative Acute Renal Failure in Patients Undergoing Cardiac Surgery.
Study Start Date : September 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
Renal Resistive Index/Nephrocheck test
Patients undergoing elective cardiac surgery with extracorporeal circulation and who are at risk to develop postoperative Acute Kidney Injury.
Procedure: Renal Resistive Index compared with NephroCheckTM



Primary Outcome Measures :
  1. Renal Resistive Index compared with NephroCheckTM [ Time Frame: Day 0 (inclusion) / after cardiac surgery ]
    Compare the effectiveness of the IRR with the NephroCheckTM to predict AKI after cardiac surgery. AKI will be defined according to the RIFLE criteria.



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 undergoing elective cardiac surgery with extracorporeal circulation and who are at risk to develop postoperative Acute Kidney Injury.
Criteria

Inclusion Criteria:

  • Elective patients
  • Patients scheduled to receive an extracorporeal circulation
  • Patients aged 60 and older
  • Patients at risk of postoperative acute kidney injury presenting at least two of the following risk factors:

    • Age > 60 years.
    • Arteritis defined as severe lower limb arteriopathy or carotid stenosis > 50%
    • Diabetes
    • Valvular or combined surgery
    • Preoperative intra-aortic balloon pump.

Exclusion Criteria:

  • Unable to provide informed consent
  • Comatose patients
  • Patients with dementia
  • Patient who underwent a previous sternotomy
  • Chronic renal failure (sCr clearance < 30 ml.min-1)
  • Renal artery stenosis
  • Endocarditis
  • Emergent surgery
  • Nephrotoxic treatment
  • Non-sinus cardiac rhythm

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): NCT02325726


Locations
Layout table for location information
France
CHU de Bordeaux
Pessac, Bordeaux, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Layout table for investigator information
Principal Investigator: Cédrick ZAOUTER, MD University Hospital, Bordeaux

Layout table for additonal information
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02325726     History of Changes
Other Study ID Numbers: CHUBX RNI 02/2014
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: November 2, 2015
Last Verified: October 2015

Keywords provided by University Hospital, Bordeaux:
Cardiac surgery
Extracorporeal circulation
Renal failure

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