NEPHROCAR: Acute Kidney Injury After Cardiac Surgery

Sponsor
Rennes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03396770
Collaborator
JRAR Association (Other)
848
1
2
44.1
19.2

Study Details

Study Description

Brief Summary

Acute kidney injury (AKI) is common after cardiac surgery. The diagnosis is based on the criteria defined by the Kidney Disease Improving Global Outcomes (KDIGO) classification: oliguria and elevation of serum creatinine. However, oliguria is not specific of AKI and elevation of serum creatinine is too late. Therefore, new methods have been developed to earlier assess the risk of AKI.

Among those methods, it has been shown that the increase of urinary dosage, in the hours following the surgery, of two proteins (Tissue Inhibitor of Metallo-Protease 2 (TIMP2) and Insulin Growth Factor Binding Protein 7 (IGFBP7)) is associated with an increased risk of occurrence of AKI in patients hospitalized in intensive care unit. The Nephrocheck® test combines the urinary dosage of those two proteins TIMP2 and IGFBP7.

Insofar as post-surgery low cardiac output is one curable cause of AKI, the early detection of early kidney risk allows corrective measures to stabilize hemodynamic state and thus to reduce the risk of AKI.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Standard clinical routine
  • Procedure: Nephrocheck test
N/A

Detailed Description

The usual diagnostic markers of AKI are defaulted. Indeed, oliguria tends to overstate the impact of AKI, up to 40-50% of patients. Postoperative increased serum creatinine is a late marker for the AKI. Furthermore, perioperative hemodilution and serum creatinine kinetic delay the postoperative peak of serum creatinine from 48 to 72 h.

Nephrocheck® test combines the urinary dosage of 2 proteins (TIMP2 and IGFBP7). These 2 proteins are excreted by the tubular cell in case of suffering whatever the origin, for example tissue hypoxia by low renal blood flow or a systemic inflammatory response. In a medical ICU, the test performed within 4 to 12 hours after kidney aggression can predict the onset of persistent AKI beyond 4 weeks.

Until randomization, all patients are treated according to the standard of care for the center. This includes a blood test upon arrival in the intensive care unit and continuous monitoring of vital parameters.

Study Design

Study Type:
Interventional
Actual Enrollment :
848 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
open labeled randomized clinical trialopen labeled randomized clinical trial
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Impact of the Early Hemodynamic Evaluation Guided by Urinary Biomarkers on the Acute Kidney Injury After Cardiac Surgery
Actual Study Start Date :
Jan 14, 2018
Actual Primary Completion Date :
Sep 16, 2021
Actual Study Completion Date :
Sep 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control group

Standard clinical routine

Procedure: Standard clinical routine
Patient management is carried out according to the usual service protocol

Experimental: Nephrocheck group

Nephrocheck test

Procedure: Nephrocheck test
Nephrocheck® test is realized 4 hours after the end of the cardiopulmonary bypass If the test is positive, hemodynamic evaluation is carried out and adapted therapy to result of this evaluation is initiated. If the test is negative, patient management is carried out according to the usual protocol. A second test is realized 6 hours after the first test whatever the result of it.

Outcome Measures

Primary Outcome Measures

  1. Occurence of an AKI according to the KDIGO classification without oliguria [72 hours after surgery]

    According to the KDIGO classification: Stage 1; Increase in serum creatinine ≥ 26.5 μmol / l or 1.5 to 1.9 times baseline serum creatinine Stage 2; Increase in baseline serum creatinine from 2.0 to 2.9 times Stage 3; An increase of 3.0 times the baseline serum creatinine or serum creatinine ≥ 354 μmol / l or initiation of renal replacement therapy

Secondary Outcome Measures

  1. Filling solute volumes [48 hours after surgery]

    Recording of the filling solute volumes administered within 48 hours postoperatively

  2. Use of catecholamin [48 hours after surgery]

    Recording (YES/NO) of the recourse of catecholamin required during the medical care, within 48 hours postoperatively

  3. Special extra corporeal circulation [48 hours after surgery]

    Recording (YES/NO) of the recourse of a particular extracorporeal system within 48 hours postoperatively : Extracorporeal Life Support, heart pumps (Impela® like devices), or Intra-aortic balloon pump.

  4. Duration of stay in the ward [Up to 28 days post surgery]

  5. Oliguria [48 hours after surgery]

    Proportion of patients with an oliguria defined according to the KDIGO criteria : Stade 1 ; diuresis < 0.5 mL/kg/h for 6 à 12 h Stade 2 ; diuresis < 0.5 mL/kg/h for more than 12h Stade 3 ; diuresis < 0.3 mL/kg/h for more than 24h or anuria ≥ 12h ;

  6. Repeatability of the Nephrocheck® test [10 hours post surgery]

    Only for the patients in the Nephrocheck arm, variations between pre and postoperative Nephrocheck® test results will be assessed

  7. Mortality rate [Up to 28 days post surgery]

    Mortality rate in the ward

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • On-pump cardiac surgery ;

  • Informed and written consent of the patient or inclusion according to the emergency procedure;

  • Affiliated patient or beneficiary of a social protection

Exclusion criteria:
  • Left and / or right ventricular assist device;

  • Heart transplant;

  • Chronic kidney disease with renal replacement therapy before surgery;

  • Hemorrhagic shock requiring surgical hemostasis at the time of randomization

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rennes University Hospital Rennes France 35000

Sponsors and Collaborators

  • Rennes University Hospital
  • JRAR Association

Investigators

  • Principal Investigator: Sébastien BIEDERMANN, MD, CHU Rennes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT03396770
Other Study ID Numbers:
  • 35RC17_8822
  • 2017-A01935-48
First Posted:
Jan 11, 2018
Last Update Posted:
Dec 2, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rennes University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 2, 2021