Clinical trial NCT02325726: RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery.
Official title: Renal Resistive Index Compared With NephroCheckTM to Predict Postoperative Acute Renal Failure in Patients Undergoing Cardiac Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Extracorporeal Circulation
Nephrocheck
Renal Failure
Keywords: Cardiac surgery
Extracorporeal circulation
Renal failure
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility 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

Primary outcomes:
measure: Renal Resistive Index compared with NephroCheckTM
timeFrame: Day 0 (inclusion) / after cardiac surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU de Bordeaux
state: Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Cédrick ZAOUTER, MD
role: PRINCIPAL_INVESTIGATOR
References: