Clinical trial NCT01864252: Investigation Into the Role of GTN & RIPC in Cardiac Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Reperfusion Injury
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: University College London Hospitals
First posted: 2013-05-29
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).

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 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

Primary outcomes:
measure: Troponin T area under the curve
timeFrame: 72 hours
Secondary outcomes:
measure: Inotrope/Vasopressor requirements peri-operatively
timeFrame: Post-operative day 1,2,3 and 4
measure: Ventilator dependence post operatively
timeFrame: Post-operative day 1,2,3 and 4
measure: Incidence of Acute Kidney Injury assessed using biomarkers
timeFrame: Post-operative day 1,2,3 and 4
measure: Length of ITU stay
timeFrame: Average 4 days
measure: Length of hospital stay
timeFrame: Average 14 days
measure: Incidence of post-operative atrial fibrillation
timeFrame: Post-operative day 1,2,3 and 4
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Heart Hospital, UCL Hospitals NHS Trust
Study officials:
affiliation: The Hatter Cardiovascular Institute
name: Derek Yellon, PhD DSc FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamarneh A, Sivaraman V, Bulluck H, Shanahan H, Kyle B, Ramlall M, Chung R, Jarvis C, Xenou M, Ariti C, Cordery R, Yellon DM, Hausenloy DJ. The Effect of Remote Ischemic Conditioning and Glyceryl Trinitrate on Perioperative Myocardial Injury in Cardiac Bypass Surgery Patients: Rationale and Design of the ERIC-GTN Study. Clin Cardiol. 2015 Nov;38(11):641-6. doi: 10.1002/clc.22445. Epub 2015 Sep 28.