An Observational Case Control Study to Identify the Role of MV and MV Derived Micro-RNA in Post CArdiac Surgery AKI

NCT02315183 | Completed DMC

• 1 other identifier: 0419
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Acute kidney injury (AKI) complicates over 25% of cardiac surgical procedures where it increases mortality up to fourfold. The incidence of AKI is increasing, the pathogenesis 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 an NHS priority. The primary aim of this study is to determine how plasma derived microvesicles (MV) or more specifically MV associated microRNAs (miRNA) regulate survival and signalling in post cardiac surgery AKI. The study involves a clinical and experimental research project that will combine laboratory analyses of circulating MV and miRNA from clinical studies. The study will specifically consider how MV and miRNA alter inflammatory signaling in kidneys after cardiac surgery, how these are modified by important clinical risk factors, and whether they may serve as early biomarkers of injury.

Conditions

Acute Kidney Injury

Keywords

Post cardiac surgery

Outcome Measures

Primary Outcomes (1)

• AKI defined according to the KDIGO criteria or by urine NGAL levels >150nmol/mg at 6 hours postoperatively.

  2 Years

Secondary Outcomes (7)

• Data on demographics, perioperative clinical characteristics and medications.

  2 Years

• MV will be isolated from arterial blood samples collected prior to anaesthetic induction, at chest closure and at 6 and 24 hours postoperatively, and characterised using flow cytometry and NanoSight LM10 (Nanosight, London, UK).

  2 Years

• Likely sources of MV will also be evaluated; Platelet and monocyte activation and aggregation will be determined by flow cytometry, endothelial activation will be determined by ELISA measurement of circulating ICAM and E-selectin in serum.

  2 Years

• MV associated miRNA profiles will be determined using microarray in patients with AKI (n=6 diabetic, n=6 non diabetic) and a matched control group (n=6 diabetic, n=6 non diabetic) without AKI.

  2 Years

• The systemic inflammatory response will be quantified by measurement of serum IL-8 and IL-6.

  2 Years

Interventions

This is an observational Study OTHER

THis study has no intervention

Also known as: MaRACAS Study

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be carried out at a large tertiary academic cardiac surgery unit in the UK; the University Hospitals of Leicester NHS Trust. This unit performs over 1,200 major cardiac procedures per year, of which 300 are expected to develop acute kidney injury.

You may qualify if:

• Adult cardiac surgery patients (\>16 years) undergoing coronary artery bypass grafting or valve surgery with moderately hypothermic CPB (32-34°C) blood cardioplegia.
• Identified as being at increased risk for AKI from a modified risk score.

You may not qualify if:

• Patients with pre-existing inflammatory state: sepsis undergoing treatment, acute kidney injury within 5 days, chronic inflammatory disease, congestive heart failure,
• Emergency or salvage procedure,
• Ejection fraction \<30 %,
• Patient in a critical preoperative state (Kidney Disease: Improving Global Outcomes (KDIGO) Stage 3 AKI or requiring ionotropes, ventilation or intra-aortic balloon pump).
• Pregnancy.

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

Department of Cardiovascular Sciences.

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and Urine samples are taken at numerous timepoints upto 5 days post cardiac surgery.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

• Gavin Murphy, Prof

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 11, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 16, 2024

Record last verified: 2014-12

Locations

GB (1)