Trial | NCT01864252  Report issue

Title

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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    192
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).
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.
Study Started
Jan 31
2014
Primary Completion
Oct 31
2018
Study Completion
Feb 28
2019
Last Update
Sep 25
2019

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.

Group 1 Control (65 patients) Sham Comparator

Sham Remote ischaemic preconditioning with IV normal saline 2-5ml/hour.

Group 2 (65 patients) Active Comparator

Patients administered a Remote Ischaemic preconditioning protocol (three-5 min cycles of simultaneous inflation to cuffs placed on upper arm and thigh) prior to surgery and IV normal saline 2-5 mL/h during surgery.

Group 3 GTN (65 patients): Experimental

Patients administered sham simulated Remote Ischaemic Preconditioning protocol prior to surgery and IV Glyceryl Trinitrate 2-5ml/h during surgery.

• Group 4 RIPC+GTN (65 patients): Experimental

Patients administered Remote Ischaemic Preconditioning protocol and IV Glyceryl Trinitrate during surgery

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
No Results Posted