Acute Kidney Injury After Cardiac Surgery

Acute Kidney Injury Clinical Trial

— NEPHROCAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03396770
• Other study ID #: 35RC17_8822
• Secondary ID: 2017-A01935-48
• Status: Completed
• Phase: N/A
• Start date: January 14, 2018
• Est. completion date: September 16, 2021

Study information

• Verified date: December 2021
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 848
• Est. completion date: September 16, 2021
• Est. primary completion date: September 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiac Surgery
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	JRAR Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of an AKI according to the KDIGO classification without oliguria	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	72 hours after surgery
Secondary	Filling solute volumes	Recording of the filling solute volumes administered within 48 hours postoperatively	48 hours after surgery
Secondary	Use of catecholamin	Recording (YES/NO) of the recourse of catecholamin required during the medical care, within 48 hours postoperatively	48 hours after surgery
Secondary	Special extra corporeal circulation	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.	48 hours after surgery
Secondary	Duration of stay in the ward		Up to 28 days post surgery
Secondary	Oliguria	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 ;	48 hours after surgery
Secondary	Repeatability of the Nephrocheck® test	Only for the patients in the Nephrocheck arm, variations between pre and postoperative Nephrocheck® test results will be assessed	10 hours post surgery
Secondary	Mortality rate	Mortality rate in the ward	Up to 28 days post surgery