Acute Kidney Injury Following Paediatric Cardiac Surgery

NCT02289040 | Completed DMC

• 2 other identifiers: 046314/EM/1136
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Acute Kidney Injury

Keywords

Acute Kidney Injury; Microvesicles; microRNA; Paediatric cardiac surgery

Outcome Measures

Primary Outcomes (2)

• change from baseline in annexin V positive microvesicles

  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.

  Pre-operatively, 6-12 hrs post-op and 24 hrs post-op

• change from baseline in microvesicles derived miRNA

  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.

  Pre-operatively, 6-12 hrs post-op and 24 hrs post-op

Secondary Outcomes (10)

• Eligibility

  pre-operatively

• Recruitment

  preoperatively

• Protocol non-adherence

  Pre-operatively, 6-12 hrs post-op and 24 hrs post-op

• Acute Kidney Injury

  preoperatively, postoperatively every day until day 7

• Variation in Renal inflammation

  Pre-operatively, 6-12 hrs post-op and 24 hrs post-op

Study Arms (1)

Children undergoing cardiac surgery

Paediatric patients (\<17 years with a body weight \>2000g) undergoing cardiac surgery for congenital heart disease with extracorporeal circulation

Procedure: cardiac surgery

Interventions

cardiac surgery PROCEDURE

cardiac surgery with extracorporeal circulation for congenital heart disease

Children undergoing cardiac surgery

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children undergoing cardiac surgery in a tertiary academic cardiac surgery unit

You may qualify if:

• Patients undergoing congenital heart operations with cardio-pulmonary bypass.
• Patients aged ≤ 17 years of age.
• Patients with a body weight \> 2kg.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leicester: lead
• University Hospitals, Leicester: collaborator
• Heart Link Children's Charity: collaborator
• British Heart Foundation: collaborator

Study Sites (1)

Glenfield Hospital

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Related Publications (1)

• Sullo N, Mariani S, JnTala M, Kumar T, Wozniak MJ, Smallwood D, Pais P, Westrope C, Lotto A, Murphy GJ. An Observational Cohort Feasibility Study to Identify Microvesicle and Micro-RNA Biomarkers of Acute Kidney Injury Following Pediatric Cardiac Surgery. Pediatr Crit Care Med. 2018 Sep;19(9):816-830. doi: 10.1097/PCC.0000000000001604.

  PMID: 29912813 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* serum * EDTA plasma * citrated blood * hirudin blood * urine

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Gavin J Murphy, Prof

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: November 13, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 30, 2020

Record last verified: 2017-05

Locations

GB (1)