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Completed

NCT Number: NCT01864252

Investigation Into the Role of GTN & RIPC in Cardiac Surgery

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).

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Key information

Conditions

Myocardial Reperfusion Injury Cardiomyopathies Cardiovascular Diseases Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Heart Hospital, UCL Hospitals NHS Trust

London, NW1 2PG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote ischaemic preconditioning

Other

3 cycles of 5 minutes to arm and legs

IV normal saline

Drug

Normal saline IV started prior to knife to skin at a rate of 2-5 mls/h and stopped just after weaning off bypass.

IV Glyceryl trinitrate 2-5ml/h

Drug

IV GTN given during surgery started prior to knife to skin and stopped after weaning off cardiopulmonary bypass.

Primary outcomes

  1. Troponin T area under the curve

    Time frame: 72 hours

    Troponin T area under the curve will be calculated using blood samples collected at 0,6,12,24,48 and 72 hours plotting it against time to calculated AUC.

Secondary outcomes

  1. Inotrope/Vasopressor requirements peri-operatively

    Time frame: Post-operative day 1,2,3 and 4

    The inotrope score will be calculated as follows:

    Dosages (in μg/kg/min) of [Dopamine + Dobutamine] + [(Adrenaline + Noradrenaline + Isoproterenol + Isoproterenol) x 100] + [(Enoximone + Milrinone) x 15]

  2. Ventilator dependence post operatively

    Time frame: Post-operative day 1,2,3 and 4

    The duration of endotracheal intubation will be noted in hours. Re-intubation rates will be calculated by noting down the number of patients requiring re-intubation and comparing this amongst the 4 groups.

  3. Incidence of Acute Kidney Injury assessed using biomarkers

    Time frame: Post-operative day 1,2,3 and 4

    Serum creatinine levels will be noted in the first 3 days postoperatively. If a patient requires renal replacement therapy, this will be recorded and comparisons made amongst the groups. Hourly urine output and daily urine volumes for the duration of ITU stay will be recorded.

  4. Length of ITU stay

    Time frame: Average 4 days

    A record of stay in days will be noted

  5. Length of hospital stay

    Time frame: Average 14 days

    Duration of hospital stay will be recorded in days

  6. Incidence of post-operative atrial fibrillation

    Time frame: Post-operative day 1,2,3 and 4

    Atrial fibrillation will be diagnosed using ECG. A record of the number of patients developing AF post operatively, the intervention used to treat it and whether or not the patient reverted to sinus rhythm prior to ITU discharge will be documented

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • University College London Hospitals

Registry information

Official study title

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

Acronym: ERIC-GTN

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
May 29, 2013
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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