- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02289040
Acute Kidney Injury Following Paediatric Cardiac Surgery (p-MiVAKI)
A Feasibility Study to Consider the Role of Microvesicles (MV) and MV Derived microRNA (miRNA) in Acute Kidney Injury (AKI) Following Paediatric Cardiac Surgery: p-MiVAKI Study
Study Overview
Detailed Description
This is a prospective, single-centre observational feasibility study that will measure changes in MV signalling and their relationship to inflammatory responses after cardiac surgery in children.
The investigators primary hypothesis is that inflammatory renal injury following paediatric cardiac surgery is regulated by circulating MV and more specifically MV associated miRNA.
The investigators secondary hypotheses are:
- MV derived signals will differ in cyanotic patients, a patient group at significantly increased risk for AKI.
- MV subsets and/or MV derived miRNA may act as novel diagnostic biomarkers for AKI.
To assist with the design of a prospective observational study that will test these hypotheses the investigators propose to undertake a feasibility study in 24 children. The objectives of this feasibility study are:
A.To establish the numbers of patients that are eligible for enrolment in the study, the number recruited to the study, and their clinical and demographic characteristics.
B.To determine the proportion of consented patients who develop AKI following cardiac surgery.
C.To measure perioperative changes in MV subgroups and MV associated miRNA, as well as platelet and monocyte activation, and the variance of these measures.
D.To establish protocol adherence, with respect to the adequacy and timing of the blood samples that are taken and the calculation of creatinine clearance perioperatively.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Leicestershire
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Leicester, Leicestershire, United Kingdom, LE3 9QP
- Glenfield Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing congenital heart operations with cardio-pulmonary bypass.
- Patients aged ≤ 17 years of age.
- Patients with a body weight > 2kg.
Exclusion Criteria:
- Patients with pre-existing inflammatory state: sepsis undergoing treatment, acute kidney injury within 5 days or chronic inflammatory disease.
- Emergency (operation before the beginning of the next working day after decision to operate) or salvage procedure (patients requiring cardiopulmonary resuscitation - external cardiac massage - en route to the operating theatre or prior to induction of anaesthesia. This does not include cardiopulmonary resuscitation following induction of anaesthesia)
- Patients where Extracorporeal Membrane Oxygenation (ECMO) support is required.
- Patients likely to require ECMO postoperatively.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Children undergoing cardiac surgery
Paediatric patients (<17 years with a body weight >2000g) undergoing cardiac surgery for congenital heart disease with extracorporeal circulation
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cardiac surgery with extracorporeal circulation for congenital heart disease
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change from baseline in annexin V positive microvesicles
Time Frame: Pre-operatively, 6-12 hrs post-op and 24 hrs post-op
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Mean plasma concentration of Annexin V positive MV and the concentration variance in plasma from arterial blood samples collected prior to anaesthetic induction, and at 6-12 and 24 hours postoperatively.
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Pre-operatively, 6-12 hrs post-op and 24 hrs post-op
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change from baseline in microvesicles derived miRNA
Time Frame: Pre-operatively, 6-12 hrs post-op and 24 hrs post-op
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Mean plasma concentration of MV derived miRNA and the concentration variance in plasma from arterial blood samples collected prior to anaesthetic induction, and at 6-12 and 24 hours postoperatively.
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Pre-operatively, 6-12 hrs post-op and 24 hrs post-op
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eligibility
Time Frame: pre-operatively
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Since this is a feasibility study, the investigators will evaluate the rate of patients who are eligible among the whole population of screened patients
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pre-operatively
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Recruitment
Time Frame: preoperatively
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Since this is a feasibility study, the investigators will evaluate the rate of patients who will be recruited among the whole population of approached patients
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preoperatively
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Protocol non-adherence
Time Frame: Pre-operatively, 6-12 hrs post-op and 24 hrs post-op
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Since this is a feasibility study, the investigators will evaluate protocol non-adherence defined as the failure to obtain the specified blood volume or urine sample required for analysis at the required time.
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Pre-operatively, 6-12 hrs post-op and 24 hrs post-op
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Acute Kidney Injury
Time Frame: preoperatively, postoperatively every day until day 7
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Acute kidney injury defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
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preoperatively, postoperatively every day until day 7
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Variation in Renal inflammation
Time Frame: Pre-operatively, 6-12 hrs post-op and 24 hrs post-op
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Variation in Renal inflammation will be determined by variation in values of urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) and Liver type- Fatty Acid Binding Protein (L-FABP) and urinary nitric oxide bioavailability .
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Pre-operatively, 6-12 hrs post-op and 24 hrs post-op
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Incidence of Acute Lung Injury - Low Cardiac Output
Time Frame: preoperatively, postoperatively every day until day 7
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Acute Lung Injury (PaO2/FiO2<300mmHg)
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preoperatively, postoperatively every day until day 7
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Incidence of Low Cardiac Output
Time Frame: preoperatively, postoperatively every day until day 7
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Low Cardiac Output (the use of two or more inotropes)
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preoperatively, postoperatively every day until day 7
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Variation in pro-coagulant potential of microvesicles
Time Frame: Pre-operatively, 6-12 hrs post-op and 24 hrs post-op
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This is a measure of MV tissue factor expression and indicates the likely pro-inflammatory effect of the MV.
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Pre-operatively, 6-12 hrs post-op and 24 hrs post-op
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Variations in sources of microvesicles
Time Frame: Pre-operatively, 6 - 12 hrs post-op and 24 hrs post-op
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Sources of MV: platelet, endothelial and monocyte activation will be determined by flow cytometry.
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Pre-operatively, 6 - 12 hrs post-op and 24 hrs post-op
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Variations in systemic inflammatory cytokine response
Time Frame: Pre-operatively, 6 - 12 hrs post-op and 24 hrs post-op
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The systemic inflammatory cytokine response will be quantified by measurement of serum interleukin-8, interleukin-6, tumor necrosis factor -α, monocyte chemotactic protein -1, monocyte chemotactic protein -3, intercellular adhesion molecule, E-selectin.
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Pre-operatively, 6 - 12 hrs post-op and 24 hrs post-op
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0463
- 14/EM/1136 (Other Identifier: East Midlands - Nottingham 1 Research Ethics Committee)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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