Investigation Into the Role of GTN & RIPC in Cardiac Surgery
Information source: University College, London
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myocardial Reperfusion Injury
Intervention: Remote ischaemic preconditioning (Other); IV Normal saline (Drug); IV Glyceryl trinitrate 2-5ml/h (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University College, London Official(s) and/or principal investigator(s): Derek Yellon, PhD DSc FRCP, Principal Investigator, Affiliation: The Hatter Cardiovascular Institute
Overall contact: Derek M Yellon, PhD DSC FACC, Phone: 02034479888, Email: D.Yellon@ucl.ac.uk
Summary
The purpose of this study is to determine whether Glyceryl Trinitrate (GTN) reduces injury
to the heart during heart-lung bypass surgery in combination with the newer technique of
remote ischaemic preconditioning (RIPC).
Clinical Details
Official title: The Effect of Remote Ischaemic Preconditioning and Glyceryl Trinitrate on Peri-operative Myocardial Injury in Cardiac Bypass Surgery Patients (ERIC-GTN Study)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Troponin T area under the curve
Secondary outcome: Inotrope/Vasopressor requirements peri-operativelyVentilator dependence post operatively Incidence of Acute Kidney Injury assessed using biomarkers Length of ITU stay Length of hospital stay Incidence of post-operative atrial fibrillation
Detailed description:
Ischaemic heart disease is a leading cause of mortality in the western world. A number of
patients undergo coronary artery bypass graft (CABG) surgery as treatment for ischaemic
heart disease. With the rise of interventional procedures, patients who are coming to have
CABG surgery are higher risk1. Remote ischaemic preconditioning (RIPC) has been shown to
reduce perioperative myocardial injury (PMI) in patients having CABG even when cold blood
cardioplegia or intermittent cross clamp fibrillation is used as cardioprotective measures.
These patients have a general anaesthetic with multiple infusions including Glyceryl
Trinitrate (GTN). The use of GTN in these patients is based on theoretical assumptions of
coronary vasodilation pre operatively along with maintaining graft potency postoperatively.
We intend to investigate the effect of GTN in patients undergoing cardiac surgery being
subjected to RIPC in its role as a Nitric Oxide (NO) donor. Exogenous NO has been shown to
be cardioprotective in animal models.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age > 18 years all patients admitted for on- pump CABG and/or valve surgery
- Able to give consent
Exclusion Criteria:
- Allergies to excipients of IMP and placebo
- Chronic Renal failure (eGFR<30 ml/min/kg)
- Severe liver disease
- Peripheral arterial disease
- Pregnant or lactating women
Locations and Contacts
Derek M Yellon, PhD DSC FACC, Phone: 02034479888, Email: D.Yellon@ucl.ac.uk
The Heart Hospital, UCL Hospitals NHS Trust, London NW1 2PG, United Kingdom; Recruiting Ashraf Hamarneh, MBchB,MRCP, Phone: 02034479781, Email: a.hamarneh@ucl.ac.uk Derek M Yellon, PhD DSc FACC, Principal Investigator Derek J Hausenloy, MD PhD FRCP, Principal Investigator Ashraf Hamarneh, MBchB MRCP, Sub-Investigator Shyam Kolvekar, MS MCh FRCS, Sub-Investigator Roger Cordery, BSc FRCA, Sub-Investigator Vivek Sivaraman, MRCP MD FRCA, Sub-Investigator
Additional Information
Starting date: January 2014
Last updated: July 7, 2015
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