Surgery Clinical Trial - Evaluation of AKI by Measuring the NephroCheck

Status Not yet recruiting

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 .

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03963284
Study type	Observational
Source	Shanghai Children's Medical Center
Contact	Xi Mo, Doctor
Phone	8618930830620
Email	moxi@scmc.com.cn
Status	Not yet recruiting
Phase
Start date	June 2019
Completion date	June 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms