NCT02325726

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

2 months

First QC Date

December 21, 2014

Last Update Submit

October 30, 2015

Conditions

Cardiac SurgeryExtracorporeal CirculationNephrocheckRenal Failure

Keywords

Cardiac surgeryExtracorporeal circulationRenal failure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

Renal Resistive Index compared with NephroCheckTMPROCEDURE
Renal Resistive Index/Nephrocheck test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Pessac, Bordeaux, 33604, France

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Cédrick ZAOUTER, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2014

First Posted

December 25, 2014

Study Start

September 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 2, 2015

Record last verified: 2015-10

Locations

FR(1)