Clinical Trial: Investigation Into the Role of GTN & RIPC in Cardiac Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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).

Detailed Summary: 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.
Sponsor: University College, London

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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]

  • 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.
  • 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.
  • Length of ITU stay [ Time Frame: Average 4 days ]
    A record of stay in days will be noted
  • Length of hospital stay [ Time Frame: Average 14 days ]
    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 ]
    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


Original Secondary Outcome: Same as current

Information By: University College, London

Dates:
Date Received: April 29, 2013
Date Started: January 2014
Date Completion: February 2016
Last Updated: July 7, 2015
Last Verified: July 2015