Investigation Into the Role of GTN & RIPC in Cardiac Surgery
NCT ID: NCT01864252
Last Updated: 2019-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
192 participants
INTERVENTIONAL
2014-01-31
2019-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Group 1 Control (65 patients)
Sham Remote ischaemic preconditioning with IV normal saline 2-5ml/hour.
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.
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.
Remote ischaemic preconditioning
3 cycles of 5 minutes to arm and legs
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.
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.
IV Glyceryl trinitrate 2-5ml/h
IV GTN given during surgery started prior to knife to skin and stopped after weaning off cardiopulmonary bypass.
• Group 4 RIPC+GTN (65 patients):
Patients administered Remote Ischaemic Preconditioning protocol and IV Glyceryl Trinitrate during surgery
Remote ischaemic preconditioning
3 cycles of 5 minutes to arm and legs
IV Glyceryl trinitrate 2-5ml/h
IV GTN given during surgery started prior to knife to skin and stopped after weaning off cardiopulmonary bypass.
Interventions
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Remote ischaemic preconditioning
3 cycles of 5 minutes to arm and legs
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.
IV Glyceryl trinitrate 2-5ml/h
IV GTN given during surgery started prior to knife to skin and stopped after weaning off cardiopulmonary bypass.
Eligibility Criteria
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Inclusion Criteria
* Able to give consent
Exclusion Criteria
* Chronic Renal failure (eGFR\<30 ml/min/kg)
* Severe liver disease
* Peripheral arterial disease
* Pregnant or lactating women
18 Years
ALL
No
Sponsors
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University College London Hospitals
OTHER
University College, London
OTHER
Responsible Party
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Principal Investigators
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Derek Yellon, PhD DSc FRCP
Role: PRINCIPAL_INVESTIGATOR
The Hatter Cardiovascular Institute
Locations
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The Heart Hospital, UCL Hospitals NHS Trust
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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120541
Identifier Type: -
Identifier Source: org_study_id
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