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

Cardiac Surgery Clinical Trial

Official title:

Renal Resistive Index Compared With NephroCheckTM to Predict Postoperative Acute Renal Failure in Patients Undergoing Cardiac Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325726
• Other study ID #: CHUBX RNI 02/2014
• Status: Completed
• Phase: N/A
• First received: December 21, 2014
• Last updated: October 30, 2015
• Start date: September 2014
• Est. completion date: November 2014

Study information

• Verified date: October 2015
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiac Surgery
• Extracorporeal Circulation
• Nephrocheck
• Renal Failure
• Renal Insufficiency

Intervention

Procedure:
• Renal Resistive Index compared with NephroCheckTM

Locations

Country	Name	City	State
France	CHU de Bordeaux	Pessac	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal Resistive Index compared with NephroCheckTM	Compare the effectiveness of the IRR with the NephroCheckTM to predict AKI after cardiac surgery. AKI will be defined according to the RIFLE criteria.	Day 0 (inclusion) / after cardiac surgery	No