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

This study is not yet open for participant recruitment.
Verified May 2013 by University College, London
Sponsor:
Collaborator:
The Heart Hospital, UCL Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01864252
First received: April 29, 2013
Last updated: October 31, 2013
Last verified: May 2013

April 29, 2013
October 31, 2013
December 2013
December 2015   (final data collection date for primary outcome measure)
Troponin T area under the curve [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01864252 on ClinicalTrials.gov Archive Site
  • Inotrope/Vasopressor requirements peri-operatively [ Time Frame: Post-operative day 1,2,3 and 4 ] [ Designated as safety issue: No ]

    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]

  • Ventilator dependence post operatively [ Time Frame: Post-operative day 1,2,3 and 4 ] [ Designated as safety issue: No ]
    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.
  • Incidence of Acute Kidney Injury assessed using biomarkers [ Time Frame: Post-operative day 1,2,3 and 4 ] [ Designated as safety issue: No ]
    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.
  • Length of ITU stay [ Time Frame: Average 4 days ] [ Designated as safety issue: No ]
    A record of stay in days will be noted
  • Length of hospital stay [ Time Frame: Average 14 days ] [ Designated as safety issue: No ]
    Duration of hospital stay will be recorded in days
  • Incidence of post-operative atrial fibrillation [ Time Frame: Post-operative day 1,2,3 and 4 ] [ Designated as safety issue: No ]
    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
Same as current
Not Provided
Not Provided
 
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)

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Reperfusion Injury
  • 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.
  • Sham Comparator: Group 1 Control (65 patients)
    Sham Remote ischaemic preconditioning with IV normal saline 2-5ml/hour.
    Intervention: Drug: IV Normal saline
  • 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.
    Interventions:
    • Other: Remote ischaemic preconditioning
    • Drug: IV Normal saline
  • 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.
    Intervention: Drug: IV Glyceryl trinitrate 2-5ml/h
  • Experimental: • Group 4 RIPC+GTN (65 patients):
    Patients administered Remote Ischaemic Preconditioning protocol and IV Glyceryl Trinitrate during surgery
    Interventions:
    • Other: Remote ischaemic preconditioning
    • Drug: IV Glyceryl trinitrate 2-5ml/h
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
260
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Derek M Yellon, PhD DSC FACC 02034479888 D.Yellon@ucl.ac.uk
Contact: Vivek Sivaraman, MRCP MD FRCA 02034479888 Vivek.Sivaraman@ucl.ac.uk
United Kingdom
 
NCT01864252
120541
Yes
University College, London
University College, London
The Heart Hospital, UCL Hospitals NHS Foundation Trust
Principal Investigator: Derek Yellon, PhD DSc FRCP The Hatter Cardiovascular Institute
University College, London
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP