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Acute Kidney Injury Following Paediatric Cardiac Surgery

NCT02289040 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2020-01-30

No results posted yet for this study

Summary

Acute kidney injury (AKI) complicates over 50% of cardiac surgical procedures in children where it increases morbidity and the use of healthcare resources. The pathogenesis of AKI is poorly understood, current diagnostic tests lack specificity and sensitivity, and there is no effective treatment. Improving outcomes in patients at risk of AKI has recently been defined as a National Health Service priority. The investigators are currently undertaking a program of work that is evaluating the role of plasma-derived microvesicles (MV) and MV associated microRNAs (miRNA) as diagnostic biomarkers or therapeutic targets in cardiac surgery patients at risk of developing AKI. Preliminary results indicate that these biomarkers may have clinical utility in adults. An important consideration is whether these biomarkers also have utility in children undergoing cardiac surgery. Measurement of MV at serial time points in children presents ethical challenges related to conducting clinical research in critically ill subjects. It also presents technical challenges related to the very small volumes of blood that may be sampled safely from babies and infants undergoing surgery. The aim of the study is to provide estimates of the perioperative variance of MV concentrations in 24 children undergoing cardiac surgery, as well as the frequency of AKI and other adverse events, protocol adherence and recruitment rates. This will assist with the design of a subsequent prospective observational study that will consider the role of MV/miRNA in children undergoing cardiac surgery.

Conditions

Interventions

PROCEDURE

cardiac surgery

cardiac surgery with extracorporeal circulation for congenital heart disease

Sponsors & Collaborators

  • University Hospitals, Leicester

    collaborator OTHER

  • Heart Link Children's Charity

    collaborator OTHER

  • British Heart Foundation

    collaborator OTHER

  • University of Leicester

    lead OTHER

Principal Investigators

  • Gavin J Murphy, Prof · University of Leicester

Eligibility

Min Age
1 Day
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02289040 on ClinicalTrials.gov