NCT03963284

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

6 months

First QC Date

May 21, 2019

Last Update Submit

May 23, 2019

Conditions

Acute Kidney InjuryCardiac DiseaseSurgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Test serum creatinine and urea concentration to report AKI according KDIGO guideline

    up to one year

Interventions

cardiac surgeryPROCEDURE

pediatric cardiac surgery with cardiopulmonary bypass

NephroCheck testDEVICE

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

Eligibility Criteria

Age28 Days - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 27429538RESULT

  • 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.

    PMID: 21336114RESULT

  • 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.

    PMID: 22878115RESULT

  • Tao 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.

    PMID: 35211796DERIVED

MeSH Terms

Conditions

Acute Kidney InjuryHeart Diseases

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Central Study Contacts

Xi Mo, Doctor

CONTACT

8618930830620moxi@scmc.com.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 24, 2019

Study Start

June 1, 2019

Primary Completion

December 1, 2019

Study Completion

June 1, 2020

Last Updated

May 24, 2019

Record last verified: 2019-05