NCT00244283

Brief Summary

To compare two different methods of protecting heart muscle from damage caused by a decreased blood supply. Exposure to the anaesthetic agent sevoflurane can allow the heart muscle to resist longer periods of low blood or oxygen supply without sustaining the amount of damage that it would otherwise expect to. The use of thoracic epidural analgesia improves the blood flow to the heart muscle and has also been shown to reduce the amount of damage the heart muscle may otherwise sustain. The aim of this study is to compare these two methods.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
unknown

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

October 24, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

October 26, 2005

Status Verified

October 1, 2005

First QC Date

October 24, 2005

Last Update Submit

October 24, 2005

Conditions

Coronary Artery Bypass Surgery

Keywords

Myocardial preconditioninganestheticsepidural anesthesiasevofluraneNT proBNP

Outcome Measures

Primary Outcomes (1)

  • Plasma concentration of NT-proBNP as a biochemical marker of ventricular dysfunction

Secondary Outcomes (2)

  • Changes in plasma measurements of cardiac troponin I and CK-MB from baseline over the first two poatoperative days.

  • Cardiac morbidity/ mortality as defined by incidence of death, inotrope requirements, arrhythmias, left ventricular dysfunction, pulmonary oedema or myocardial infarction

Interventions

SevofluraneDRUG
High thoracic epidural analgesiaPROCEDURE

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting for elective CABG operations, with \>40 % left ventricular ejection fraction, aged 40-80.

You may not qualify if:

  • Patients at risk of epidural haematomas (i.e. platelets \<100, coagulopathies, on anticoagulant therapies, INR\>1.4) or unsuited to HTEA (patient refusal, spinal deformities).
  • Patients on drugs shown to manipulate the preconditioning phenomenon will also be excluded. This includes those on diazoxide, nicorandil, oral sulfonylureas and theophyllines.
  • Patients with preoperative ECG morphologies likely to make interpretation difficult or impossible including: left bundle branch block, cardiac pacemaker dependence.
  • Haemodynamically compromised patients requiring inotropic or balloon pump support preoperatively.
  • Significant valvular disease. Preoperative elevated levels of troponin I or CKMB. Unstable angina or angina in 24 hours preop

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Golden Jubilee National Hospital

Glasgow, G81 4HX, United Kingdom

Location

Related Publications (2)

  • Julier K, da Silva R, Garcia C, Bestmann L, Frascarolo P, Zollinger A, Chassot PG, Schmid ER, Turina MI, von Segesser LK, Pasch T, Spahn DR, Zaugg M. Preconditioning by sevoflurane decreases biochemical markers for myocardial and renal dysfunction in coronary artery bypass graft surgery: a double-blinded, placebo-controlled, multicenter study. Anesthesiology. 2003 Jun;98(6):1315-27. doi: 10.1097/00000542-200306000-00004.

    PMID: 12766638BACKGROUND

  • Berendes E, Schmidt C, Van Aken H, Hartlage MG, Wirtz S, Reinecke H, Rothenburger M, Scheld HH, Schluter B, Brodner G, Walter M. Reversible cardiac sympathectomy by high thoracic epidural anesthesia improves regional left ventricular function in patients undergoing coronary artery bypass grafting: a randomized trial. Arch Surg. 2003 Dec;138(12):1283-90; discussion 1291. doi: 10.1001/archsurg.138.12.1283.

    PMID: 14662525BACKGROUND

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Stefan Schraag, MD PhD

    Golden Jubilee National Hospital

    STUDY DIRECTOR

  • Martin F McCormick, MB ChB

    Golden Jubilee National Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin F McCormick, MB ChB

CONTACT

44 141 951 5600Martin.McCormick@gjnh.scot.nhs.uk

Stefan Schraag, MD PhD

CONTACT

44 141 951 5609Stefan.Schraag@gjnh.scot.nhs.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 24, 2005

First Posted

October 26, 2005

Study Start

January 1, 2006

Study Completion

January 1, 2008

Last Updated

October 26, 2005

Record last verified: 2005-10

Locations

GB(1)