NCT01864252

Investigation Into the Role of GTN & RIPC in Cardiac Surgery

The Effect of Remote Ischaemic Preconditioning and Glyceryl Trinitrate on Peri-operative Myocardial Injury in Cardiac Bypass Surgery Patients (ERIC-GTN Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Reperfusion Injury

Interventions

Type	Name	Description
OTHER	Remote ischaemic preconditioning	3 cycles of 5 minutes to arm and legs
DRUG	IV Normal saline	Normal saline IV started prior to knife to skin at a rate of 2-5 mls/h and stopped just after weaning off bypass.
DRUG	IV Glyceryl trinitrate 2-5ml/h	IV GTN given during surgery started prior to knife to skin and stopped after weaning off cardiopulmonary bypass.

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-10-01
• Completion: 2019-02-01
• First posted: 2013-05-29
• Last updated: 2019-09-25

Locations

1 site across 1 country: United Kingdom