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Myocardial Reperfusion InjuryPhase 3ERIC-GTNNCT01864252

Investigation Into the Role of GTN & RIPC in Cardiac Surgery

A Phase 3 study testing Remote ischaemic preconditioning, IV Normal saline and IV Glyceryl trinitrate 2-5ml/h in people with Myocardial Reperfusion Injury, run by University College, London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Reperfusion Injury
What is being tested?
Remote ischaemic preconditioning, IV Normal saline and IV Glyceryl trinitrate 2-5ml/h
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
192 participants
Where
1 siteUnited Kingdom
Study dates
Jan 2014to Feb 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 18 years all patients admitted for on- pump CABG and/or valve surgery
  • Able to give consent

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United Kingdom1 site

  • The Heart Hospital, UCL Hospitals NHS Trust

    London, NW1 2PG

Other trials in United Kingdom

About this study

Official title: 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).

Read the 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.

Being tested
Remote ischaemic preconditioning, IV Normal saline, IV Glyceryl trinitrate 2-5ml/h
Medical subject headings
Myocardial Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote ischaemic preconditioningOther

    3 cycles of 5 minutes to arm and legs

  • IV Normal salineDrug

    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/hDrug

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

Study groups in NCT01864252
Study groupRoleWhat they receive
Group 1 Control (65 patients)Sham comparatorSham Remote ischaemic preconditioning with IV normal saline 2-5ml/hour.
Receives: Drug: IV Normal saline
Group 2 (65 patients)Active comparatorPatients 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.
Receives: Other: Remote ischaemic preconditioning; Drug: IV Normal saline
Group 3 GTN (65 patients):ExperimentalPatients administered sham simulated Remote Ischaemic Preconditioning protocol prior to surgery and IV Glyceryl Trinitrate 2-5ml/h during surgery.
Receives: Drug: IV Glyceryl trinitrate 2-5ml/h
• Group 4 RIPC+GTN (65 patients):ExperimentalPatients administered Remote Ischaemic Preconditioning protocol and IV Glyceryl Trinitrate during surgery
Receives: Other: Remote ischaemic preconditioning; Drug: IV Glyceryl trinitrate 2-5ml/h

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Troponin T area under the curve

    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.

    Measured: 72 hours

Secondary outcomes (6)

  1. Inotrope/Vasopressor requirements peri-operatively

    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]

    Measured: Post-operative day 1,2,3 and 4

  2. Ventilator dependence post operatively

    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.

    Measured: Post-operative day 1,2,3 and 4

  3. Incidence of Acute Kidney Injury assessed using biomarkers

    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.

    Measured: Post-operative day 1,2,3 and 4

  4. Length of ITU stay

    A record of stay in days will be noted

    Measured: Average 4 days

  5. Length of hospital stay

    Duration of hospital stay will be recorded in days

    Measured: Average 14 days

  6. Incidence of post-operative atrial fibrillation

    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

    Measured: Post-operative day 1,2,3 and 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionOct 2018
  4. Study completionFeb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01864252
Sponsor's protocol ID
120541
Acronym
ERIC-GTN
Status last verified
Sep 2019
First submitted
29 Apr 2013
Last updated
25 Sep 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Hamarneh A, Sivaraman V, Bulluck H, Shanahan H, Kyle B, Ramlall M, Chung R, Jarvis C, Xenou M, Ariti C, Cordery R, Yellon DM, Hausenloy DJ. The Effect of Remote Ischemic Conditioning and Glyceryl Trinitrate on Perioperative Myocardial Injury in Cardiac Bypass Surgery Patients: Rationale and Design of the ERIC-GTN Study. Clin Cardiol. 2015 Nov;38(11):641-6. doi: 10.1002/clc.22445. Epub 2015 Sep 28.

    PubMed 26412308

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remote ischaemic preconditioning, IV Normal saline and IV Glyceryl trinitrate 2-5ml/h in people with Myocardial Reperfusion Injury, run by University College, London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Troponin T area under the curve (time frame: 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01864252, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.

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