Evaluation of AKI by Measuring the NephroCheck Test After Pediatric Cardiac Surgery

Surgery Clinical Trial

Official title:

Evaluation of the Incidence of Renal Stress by Measuring the NephroCheck Test After Pediatric Cardiac Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03963284
• Other study ID #: SCMC/bMX-2019-01
• Status: Not yet recruiting
• Start date: June 2019
• Est. completion date: June 2020

Study information

• Verified date: May 2019
• Source: Shanghai Children's Medical Center
• Contact: Xi Mo, Doctor
• Phone: 8618930830620
• Email: moxi[@]scmc.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiac Disease
• Heart Diseases
• Surgery

Intervention

Procedure:
• cardiac surgery
pediatric cardiac surgery with cardiopulmonary bypass

Device:
• NephroCheck test
Urine of the subjects undergoing cardiac surgery with CPB will be tested by NephroCheck test

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Children's Medical Center	BioMérieux

References & Publications (3)

Jefferies JL, Devarajan P. Early detection of acute kidney injury after pediatric cardiac surgery. Prog Pediatr Cardiol. 2016 Jun;41:9-16. — View 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 Car — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test fresh urine samples by NephroCheck	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).; - 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours after initiation of CPB	up to one year
Secondary	Test serum creatinine and urea concentration to report AKI according KDIGO guideline	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, 0 hours).; 12 hours, 24 hours, 48 hours, 60 hours after initiation of CPB	up to one year