Investigation Into the Role of GTN & RIPC in Cardiac Surgery (ERIC-GTN)

University College London (UCL)

Status and phase

Completed

Phase 3

Conditions

Myocardial Reperfusion Injury

Treatments

Drug: IV Normal saline

Other: Remote ischaemic preconditioning

Drug: IV Glyceryl trinitrate 2-5ml/h

Study type

Interventional

Funder types

Other

Identifiers

NCT01864252

120541

Details and patient eligibility

About

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).

Full 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.

Enrollment

192 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

192 participants in 4 patient groups

Group 1 Control (65 patients)

Sham Comparator group

Description:

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

Treatment:

Drug: IV Normal saline

Group 2 (65 patients)

Active Comparator group

Description:

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.

Treatment:

Drug: IV Normal saline

Other: Remote ischaemic preconditioning

Group 3 GTN (65 patients):

Experimental group

Description:

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

Treatment:

Drug: IV Glyceryl trinitrate 2-5ml/h

• Group 4 RIPC+GTN (65 patients):

Experimental group

Description: