Clinical trial NCT03963284: Evaluation of AKI by Measuring the NephroCheck Test After Pediatric Cardiac Surgery
Official title: Evaluation of the Incidence of Renal Stress by Measuring the NephroCheck Test After Pediatric Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Cardiac Disease
Surgery
Lead sponsor: Shanghai Children's Medical Center
Sponsor class: OTHER
Collaborators: name: BioMérieux
First posted: 2019-05-24
Enrollment: 350
Sex: ALL
Minimum age (years): 28
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: At least 200 subjects having undergone pediatric cardiac surgery with cardiopulmonary bypass (CPB). Enrollment will continue with a maximum of 350 subjects until 30 cases of AKI (stage 2 and 3) are reached.

Brief summary: Blood and urine samples of over 200 pediatric subjects (over 28 days to 3 years) undergoing complex cardiac surgery with cardiopulmonary bypass (CPB) will be collected at several time points to measure corresponding biomarkers such as serum creatinine, serum urea concentration, or NephroCheck test (\[TIMP-2\]\*\[IGFBP7) to evaluate the diagnostic performance of AKI by NephroCheck test .

Detailed description: At least 200 subjects having undergone pediatric cardiac surgery with cardiopulmonary bypass (CPB). Enrollment will continue with a maximum of 350 subjects until 30 cases of AKI (stage 2 and 3) are reached.

Blood and urines samples will be collected at several time points to measure biomarkers and set up a biobank.

The samples used within the scope of this protocol will be fresh urine samples (1 to 2 ml) and blood samples.

Urine samples for \[TIMP-2\]\*\[IGFBP7\] measurements will be taken from each subject included in the study during the first 48 hours following cardiopulmonary bypass initiation according to the following schedule:

* baseline before initiation of cardiopulmonary bypass (CPB, 0h).
* - 2h, 4h, 6h, 8h, 12h, 24h, 48h after initiation of CPB

Blood samples for serum creatinine and urea concentration measurement will be taken from each subject included in the study during the first 48 hours following cardiopulmonary bypass initiation according to the following schedule:

* baseline before initiation of cardiopulmonary bypass (CPB, 0h).
* 12h, 24h, 48h, 60h after initiation of CPB

Primary objective:

To evaluate the proportion of subjects predicted to be at risk of AKI (stage 2 and 3) using at least one measurement of NephroCheck in subjects having undergone pediatric cardiac surgery.

Secondary objectives:

* To evaluate the incidence of AKI (stage 2 and 3) according to the KDIGO guideline
* To study the kinetic profile of cell cycle arrest biomarkers (TIMP-2\*IGFBP-7) during the first 48 hours in subjects having undergone pediatric cardiac surgery
* To determine the baseline values of \[TIMP-2\]\*\[IGFBP7\] in the targeted population before surgery
* To determine profile differences of \[TIMP-2\]\*\[IGFBP7\] between AKI (stage 2 and 3) and non-AKI groups
* To evaluate the diagnostic performances of \[TIMP-2\]\*\[IGFBP7\] to predict AKI after pediatric cardiac surgery using a cut-off value of 0.3

Eligibility criteria: Inclusion Criteria:

* Must sign the consent form
* Clinical diagnosis of complex congenital heart surgery (Risk Adjusted classification for Congenital Heart Surgery \[RACHS\] score \>=2)
* Must undergo elective cardiac surgery with CPB

Exclusion Criteria:

* Clinical diagnosis of severe pre-existing renal insufficiency (SCr \>2 times age-adjusted normal range)
* Significant abnormalities of the kidneys or genitourinary tract

Primary outcomes:
measure: Test fresh urine samples by NephroCheck
timeFrame: up to one year
Secondary outcomes:
measure: Test serum creatinine and urea concentration to report AKI according KDIGO guideline
timeFrame: up to one year
Other outcomes:
Locations:
Study officials:
References:
citation: Jefferies JL, Devarajan P. Early detection of acute kidney injury after pediatric cardiac surgery. Prog Pediatr Cardiol. 2016 Jun;41:9-16. doi: 10.1016/j.ppedcard.2016.01.011.
citation: Li S, Krawczeski CD, Zappitelli M, Devarajan P, Thiessen-Philbrook H, Coca SG, Kim RW, Parikh CR; TRIBE-AKI Consortium. Incidence, risk factors, and outcomes of acute kidney injury after pediatric cardiac surgery: a prospective multicenter study. Crit Care Med. 2011 Jun;39(6):1493-9. doi: 10.1097/CCM.0b013e31821201d3.
citation: Morgan CJ, Zappitelli M, Robertson CM, Alton GY, Sauve RS, Joffe AR, Ross DB, Rebeyka IM; Western Canadian Complex Pediatric Therapies Follow-Up Group. Risk factors for and outcomes of acute kidney injury in neonates undergoing complex cardiac surgery. J Pediatr. 2013 Jan;162(1):120-7.e1. doi: 10.1016/j.jpeds.2012.06.054. Epub 2012 Aug 9.