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

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

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Key information

Conditions

Cardiac Surgery Extracorporeal Circulation Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrocheck Renal Failure Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux

Pessac, Bordeaux, 33604, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renal Resistive Index compared with NephroCheckTM

Procedure

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Dec 25, 2014
Registry last updated: Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed