NCT02471001

Brief Summary

In the last few years, anaesthetic agents, Isoflurane used in heart surgery have shown some benefits to reduce the risk of heart muscle damage. Many research studies have been conducted to reveal the benefit relationship between Isoflurane and the risk of heart muscle injury during heart surgery. However, there is a knowledge gap regarding the optimal level of Isoflurane concentration to confer the benefit of heart muscle-protective properties. Therefore, this study is conducted to answer that question by measuring the Isoflurane concentration in the blood vessels. It also assesses whether Isoflurane concentration in the blood is correlated to the oxygenator exhaust level of Isoflurane in the heart-lung machine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

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

June 4, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 28, 2016

Status Verified

May 1, 2016

Enrollment Period

9 months

First QC Date

June 4, 2015

Last Update Submit

November 23, 2016

Conditions

Cardiac Surgery

Keywords

concentrationIsofluranecardioprotectivecardioplegiaheart surgeryDisorderHeartFunctionalPostoperative

Outcome Measures

Primary Outcomes (1)

  • Levels of Isoflurane in coronary sinus blood

    1 week after blood samples taken

Secondary Outcomes (1)

  • Isoflurane level in oxygenator exhaust levels on heart-lung machine

    Immediately after the heart surgery is over

Study Arms (1)

Heart Surgery Using Heart-lung Machine

All patients who scheduled for an elective heart surgery in Royal Infirmary of Edinburgh using a heart-lung machine and the administration of ether-like anaesthetic, isoflurane will be recruited in this study. The medical and surgical care plans for participants remain as usual in this study with an exception being two additional blood samples of about two-teaspoonful in volume will be collected from an in-placed catheters in vein and aorta.

Biological: Blood samples

Interventions

Blood samplesBIOLOGICAL

Two additional blood samples will be taken from in-situ catheters during heart surgery.

Heart Surgery Using Heart-lung Machine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who scheduled for an elective heart surgery in Royal Infirmary of Edinburgh using a heart-lung machine and the administration of ether-like anaesthetic, isoflurane will be recruited in this study.

You may qualify if:

  • Age 18 years or older
  • Scheduled for elective cardiac surgery requiring cardiopulmonary bypass.
  • Anaesthetised using isoflurane as part of a balanced anaesthetic technique during heart-lung machine
  • Patient has consented to participate
  • Cardioplegia technique involves insertion of a coronary sinus catheter.

You may not qualify if:

  • Emergency surgery or patient with malignancy
  • Heart surgery undertaken without heart-lung machine
  • Age younger than 18 years
  • Unable or unwilling to provide informed consent
  • Cardiac surgery that does not require cardiopulmonary bypass
  • Anaesthetised using an total intravenous-based technique

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesia and Critical Care

Edinburgh, United Kingdom

Location

Related Publications (9)

  • Yau JM, Alexander JH, Hafley G, Mahaffey KW, Mack MJ, Kouchoukos N, Goyal A, Peterson ED, Gibson CM, Califf RM, Harrington RA, Ferguson TB; PREVENT IV Investigators. Impact of perioperative myocardial infarction on angiographic and clinical outcomes following coronary artery bypass grafting (from PRoject of Ex-vivo Vein graft ENgineering via Transfection [PREVENT] IV). Am J Cardiol. 2008 Sep 1;102(5):546-51. doi: 10.1016/j.amjcard.2008.04.069. Epub 2008 Jul 2.

    PMID: 18721510BACKGROUND

  • BIGELOW WG, LINDSAY WK, GREENWOOD WF. Hypothermia; its possible role in cardiac surgery: an investigation of factors governing survival in dogs at low body temperatures. Ann Surg. 1950 Nov;132(5):849-66. doi: 10.1097/00000658-195011000-00001. No abstract available.

    PMID: 14771796BACKGROUND

  • Yoshimi I. Cardiac preconditioning by anesthetic agents: roles of volatile anesthetics and opioids in cardioprotection. Yonago Acta Medica 2007; 50: 45-55.

    BACKGROUND

  • Hausenloy DJ, Boston-Griffiths E, Yellon DM. Cardioprotection during cardiac surgery. Cardiovasc Res. 2012 May 1;94(2):253-65. doi: 10.1093/cvr/cvs131. Epub 2012 Mar 22.

    PMID: 22440888BACKGROUND

  • R. Peter Alston, Paul Myles, Marco Ranucci. Oxford Textbook of Cardiothoracic Anaesthesia. Oxford University Press 2015. Chapter 15 Myocardial protection during cardiac surgery. 157-65.

    BACKGROUND

  • Pramood CK, Reena S, Gajraj SS. Ischemic and anesthetic preconditioning of the heart: an insight into the concepts and mechanisms. Journal Indian Academy of Clinical Medicine; 2005; 6(1): 45-7

    BACKGROUND

  • Symons JA, Myles PS. Myocardial protection with volatile anaesthetic agents during coronary artery bypass surgery: a meta-analysis. Br J Anaesth. 2006 Aug;97(2):127-36. doi: 10.1093/bja/ael149. Epub 2006 Jun 21.

    PMID: 16793778BACKGROUND

  • Fabien Picard, Francis Depret, Sergio ZC, Steven Hollenberg. Effect of anesthesia level on murine cardiac function. F1000 Research 2014; 3: 165-72

    BACKGROUND

  • Chiu-Fen Y, Michael Yu-Chih C, Tsung-I C, Ching-Feng Cheng. Dose-dependent effects of isoflurane on cardiovascular function in rats. Tzu Chi Medical Journal 2014; 26 (3): 119-22

    BACKGROUND

MeSH Terms

Conditions

Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • R Peter Alston, MB ChB

    NHS Lothian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2015

First Posted

June 12, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 28, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)