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Completed

NCT Number: NCT03396770

Acute Kidney Injury After Cardiac Surgery

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.

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Key information

Conditions

Acute Kidney Injury Cardiac Surgery Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rennes University Hospital

Rennes, 35000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Standard clinical routine

Procedure

Patient management is carried out according to the usual service protocol

Nephrocheck test

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • JRAR Association

Registry information

Official study title

Impact of the Early Hemodynamic Evaluation Guided by Urinary Biomarkers on the Acute Kidney Injury After Cardiac Surgery

Acronym: NEPHROCAR

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2018
Registry last updated
Dec 2, 2021

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.

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