Acute Kidney InjuryNCT03963284
Evaluation of AKI by Measuring the NephroCheck Test After Pediatric Cardiac Surgery
An observational study of Acute Kidney Injury and Cardiac Disease, run by Shanghai Children's Medical Center.
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)… Read more about this study
- Who is it for?
- Ages 28 days to 3 years
- Conditions the study is for
- Acute Kidney Injury, Cardiac Disease, Surgery
- What is being tested?
- cardiac surgery and NephroCheck test
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 3 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- Clinical diagnosis of severe pre-existing renal insufficiency (SCr >2 times age-adjusted normal range)
- Significant abnormalities of the kidneys or genitourinary tract
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Incidence of Renal Stress by Measuring the NephroCheck Test After Pediatric Cardiac Surgery
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 .
Read the 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
- Conditions
- Acute Kidney Injury, Cardiac Disease, Surgery
- Being tested
- cardiac surgery, NephroCheck test
- Medical subject headings
- Acute Kidney Injury, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac surgeryProcedure or surgery
pediatric cardiac surgery with cardiopulmonary bypass
NephroCheck testDevice
Urine of the subjects undergoing cardiac surgery with CPB will be tested by NephroCheck test
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to one year
Secondary outcomes (1)
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
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study startJun 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963284
- Sponsor's protocol ID
- SCMC/bMX-2019-01
- Status last verified
- May 2019
- First submitted
- 21 May 2019
- Last updated
- 24 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 27429538Li 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.
PubMed 21336114Morgan 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.
PubMed 22878115Tao Y, Heskia F, Zhang M, Qin R, Kang B, Chen L, Wu F, Huang J, Brengel-Pesce K, Chen H, Mo X, Liang J, Wang W, Xu Z. Evaluation of acute kidney injury by urinary tissue inhibitor metalloproteinases-2 and insulin-like growth factor-binding protein 7 after pediatric cardiac surgery. Pediatr Nephrol. 2022 Nov;37(11):2743-2753. doi: 10.1007/s00467-022-05477-6. Epub 2022 Feb 24.
PubMed 35211796
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Incidence of Renal Stress by Measuring the NephroCheck Test After Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03963284
- Acronym / sponsor ID
- SCMC/bMX-2019-01
- Conditions
- Acute Kidney Injury, Cardiac Disease, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Collaborators
- BioMérieux
- Study start
- Jun 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 24 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 28 days to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Clinical diagnosis of severe pre-existing renal insufficiency (SCr >2 times age-adjusted normal range)
- Significant abnormalities of the kidneys or genitourinary tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac surgerypediatric cardiac surgery with cardiopulmonary bypass | Procedure or surgery | – |
| NephroCheck testUrine of the subjects undergoing cardiac surgery with CPB will be tested by NephroCheck test | Device | – |
Primary outcome
Test fresh urine samples by NephroCheck
Time frame: up to one year
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
1 secondary outcome
Test serum creatinine and urea concentration to report AKI according KDIGO guideline
Time frame: up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Results publication: PubMed 27429538Jefferies 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.
- Results publication: PubMed 21336114Li 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.
- Results publication: PubMed 22878115Morgan 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.
- Derived from this study: PubMed 35211796Tao Y, Heskia F, Zhang M, Qin R, Kang B, Chen L, Wu F, Huang J, Brengel-Pesce K, Chen H, Mo X, Liang J, Wang W, Xu Z. Evaluation of acute kidney injury by urinary tissue inhibitor metalloproteinases-2 and insulin-like growth factor-binding protein 7 after pediatric cardiac surgery. Pediatr Nephrol. 2022 Nov;37(11):2743-2753. doi: 10.1007/s00467-022-05477-6. Epub 2022 Feb 24.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Cardiac Disease, run by Shanghai Children's Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xi Mo, Doctor (8618930830620, moxi@scmc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test fresh urine samples by NephroCheck (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03963284, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2019.