NCT03396770

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
848

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

January 14, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2021

Completed
Last Updated

December 2, 2021

Status Verified

December 1, 2021

Enrollment Period

3.7 years

First QC Date

December 15, 2017

Last Update Submit

December 1, 2021

Conditions

Acute Kidney InjuryCardiac Surgery

Keywords

Urinary biomarkersIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Filling solute volumes

    48 hours after surgery

  • Use of catecholamin

    48 hours after surgery

  • Special extra corporeal circulation

    48 hours after surgery

  • Duration of stay in the ward

    Up to 28 days post surgery

  • Oliguria

    48 hours after surgery

  • +2 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

Standard clinical routine

Procedure: Standard clinical routine

Nephrocheck group

EXPERIMENTAL

Nephrocheck test

Procedure: Nephrocheck test

Interventions

Standard clinical routinePROCEDURE

Patient management is carried out according to the usual service protocol

Control group
Nephrocheck testPROCEDURE

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.

Nephrocheck group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • On-pump cardiac surgery ;
  • Affiliated patient or beneficiary of a social protection

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35000, France

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Sébastien BIEDERMANN, MD

    CHU Rennes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: open labeled randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2017

First Posted

January 11, 2018

Study Start

January 14, 2018

Primary Completion

September 16, 2021

Study Completion

September 16, 2021

Last Updated

December 2, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)