An observational study in Acute Kidney Injury, Cardiac Disease and Surgery, sponsored by Shanghai Children's Medical Center. Status unknown. Open to participants aged 28 Days to 3 Years. Per ClinicalTrials.gov, last updated 2019-05-24.
Sponsored by Shanghai Children's Medical Center · Observational
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 .
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:
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:
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:
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's planned enrollment of 350 is above the median of 150 across 773 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Shanghai Children's Medical Center is the lead sponsor of 37 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
pediatric cardiac surgery with cardiopulmonary bypass
Urine of the subjects undergoing cardiac surgery with CPB will be tested by NephroCheck test
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
Time frame: up to one year
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
Time frame: up to one year
No study locations are listed for this record.
Plan to share: Undecided
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Children's Medical Center