NCT01864252

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

4.8 years

First QC Date

April 29, 2013

Last Update Submit

September 24, 2019

Conditions

Myocardial Reperfusion Injury

Outcome Measures

Primary Outcomes (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.

    72 hours

Secondary Outcomes (6)

  • Inotrope/Vasopressor requirements peri-operatively

    Post-operative day 1,2,3 and 4

  • Ventilator dependence post operatively

    Post-operative day 1,2,3 and 4

  • Incidence of Acute Kidney Injury assessed using biomarkers

    Post-operative day 1,2,3 and 4

  • Length of ITU stay

    Average 4 days

  • Length of hospital stay

    Average 14 days

  • +1 more secondary outcomes

Study Arms (4)

Group 1 Control (65 patients)

SHAM COMPARATOR

Sham Remote ischaemic preconditioning with IV normal saline 2-5ml/hour.

Drug: IV Normal saline

Group 2 (65 patients)

ACTIVE COMPARATOR

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 preconditioningDrug: IV Normal saline

Group 3 GTN (65 patients):

EXPERIMENTAL

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

• Group 4 RIPC+GTN (65 patients):

EXPERIMENTAL

Patients administered Remote Ischaemic Preconditioning protocol and IV Glyceryl Trinitrate during surgery

Other: Remote ischaemic preconditioningDrug: IV Glyceryl trinitrate 2-5ml/h

Interventions

Remote ischaemic preconditioningOTHER

3 cycles of 5 minutes to arm and legs

Group 2 (65 patients)• Group 4 RIPC+GTN (65 patients):
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.

Group 1 Control (65 patients)Group 2 (65 patients)
IV Glyceryl trinitrate 2-5ml/hDRUG

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

Group 3 GTN (65 patients):• Group 4 RIPC+GTN (65 patients):

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Heart Hospital, UCL Hospitals NHS Trust

London, NW1 2PG, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 26412308DERIVED

MeSH Terms

Conditions

Myocardial Reperfusion Injury

Interventions

Saline SolutionNitroglycerin

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesReperfusion InjuryPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsNitro CompoundsOrganic Chemicals

Study Officials

  • Derek Yellon, PhD DSc FRCP

    The Hatter Cardiovascular Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2013

First Posted

May 29, 2013

Study Start

January 1, 2014

Primary Completion

October 1, 2018

Study Completion

February 1, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations

GB(1)