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Trial record 15 of 52 for:    TIMP2

Acute Kidney Injury After Cardiac Surgery (NEPHROCAR)

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ClinicalTrials.gov Identifier: NCT03396770
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : December 17, 2018
Sponsor:
Collaborator:
JRAR Association
Information provided by (Responsible Party):
Rennes University Hospital

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
Acute Kidney Injury Cardiac Surgery Procedure: Standard clinical routine Procedure: Nephrocheck test Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: open 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 : January 14, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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.




Primary Outcome Measures :
  1. Occurence of an AKI according to the KDIGO classification without oliguria [ Time Frame: 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 [ Time Frame: 48 hours after surgery ]
    Recording of the filling solute volumes administered within 48 hours postoperatively

  2. Use of catecholamin [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 28 days post surgery ]
  5. Oliguria [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 28 days post surgery ]
    Mortality rate in the ward



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396770


Contacts
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Contact: Sébastien BIEDERMANN, MD +33299287040 sebastien.biedermann@chu-rennes.fr

Locations
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France
Rennes University Hospital Recruiting
Rennes, France, 35000
Contact: Sebastien BIEDERMANN, MD       sebastien.biedermann@chu-rennes.fr   
Sponsors and Collaborators
Rennes University Hospital
JRAR Association
Investigators
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Principal Investigator: Sébastien BIEDERMANN, MD CHU Rennes

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03396770     History of Changes
Other Study ID Numbers: 35RC17_8822
2017-A01935-48 ( Other Identifier: ID-RCB )
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rennes University Hospital:
Urinary biomarkers
Intensive Care Unit

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases