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

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ClinicalTrials.gov Identifier: NCT01864252
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
University College London Hospitals
Information provided by (Responsible Party):
University College, London

Study Description
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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).

Condition or disease Intervention/treatment Phase
Myocardial Reperfusion Injury Other: Remote ischaemic preconditioning Drug: IV Normal saline Drug: IV Glyceryl trinitrate 2-5ml/h Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Remote Ischaemic Preconditioning and Glyceryl Trinitrate on Peri-operative Myocardial Injury in Cardiac Bypass Surgery Patients (ERIC-GTN Study)
Actual Study Start Date : January 2014
Actual Primary Completion Date : October 2018
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Group 1 Control (65 patients)
Sham Remote ischaemic preconditioning with IV normal saline 2-5ml/hour.
 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.
Active Comparator: Group 2 (65 patients)
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.
 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.
Experimental: Group 3 GTN (65 patients):
Patients administered sham simulated Remote Ischaemic Preconditioning protocol prior to surgery and IV Glyceryl Trinitrate 2-5ml/h during surgery.
 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.
Experimental: • Group 4 RIPC+GTN (65 patients):
Patients administered Remote Ischaemic Preconditioning protocol and IV Glyceryl Trinitrate during surgery
 Other: Remote ischaemic preconditioning
3 cycles of 5 minutes to arm and legs

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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864252


Locations
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United Kingdom
The Heart Hospital, UCL Hospitals NHS Trust
London, United Kingdom, NW1 2PG
Sponsors and Collaborators
University College, London
University College London Hospitals
Investigators
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Principal Investigator: Derek Yellon, PhD DSc FRCP The Hatter Cardiovascular Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01864252    
Other Study ID Numbers: 120541
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Reperfusion Injury
Myocardial Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
 Cardiomyopathies
Heart Diseases
Myocardial Ischemia
Nitroglycerin
Vasodilator Agents