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
NA
31 participants
INTERVENTIONAL
2009-12-31
2012-01-31
Brief Summary
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The investigators hypothesis that reversal of cardiac dyssynchrony will improve tissue perfusion and cardiac haemodynamics after surgical revascularisation. This will shorten post-operative recovery in cardiac ITU.
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Detailed Description
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The investigators hypothesise that BiV pacing will reverse cardiac dyssynchrony and improve target organ perfusion. This will be significantly reduced the post operative requirement for Level 3 CITU care.
This study will compare 48 hours of temporary biventricular (BiV) pacing to enhance cardiac function against standard post-operative pacing, in patients with poor LV function undergoing cardiac surgery. Temporary biventricular (BiV) pacing will be achieved with the addition of a third pacing electrode attached to the left ventricle. Using a pulmonary arterial catheter the interventricular (VV) delay will be adjusted to yield the maximum cardiac output at constant heart rate- sequential BiV pacing. A pilot study conducted at the University Hospital of Wales (UHW) showed that this approach is likely to be successful.
The primary endpoint of the study will be the mean duration of Level 3 CITU care required by patients after cardiac surgery. Secondary endpoints will include: haemodynamic improvement with BiV pacing; post-operative renal function; atrial fibrillation (AF)/ ventricular arrhythmias; post operative inotropic requirements and changes in biomarkers- NT Pro BNP and Troponin T.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard pacing
Standard pacing settings prescribed by the cardiac surgeon or intensivist after revascularisation.
Biventricular pacing
Optimised temporary biventricular pacing.
BiVentricular pacing (BiV).
The group of patients receiving biventricular pacing after cardiac surgery.
Biventricular pacing
Optimised temporary biventricular pacing.
Interventions
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Biventricular pacing
Optimised temporary biventricular pacing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Cardiff and Vale University Health Board
OTHER_GOV
Responsible Party
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Principal Investigators
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Zaheer R Yousef, MD
Role: STUDY_DIRECTOR
Cardiff and Vale Local Heath Board, Cardiff.
Locations
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Cardiff and Vale University Health Board.
Cardiff, , United Kingdom
Morriston Hospital
Swansea, , United Kingdom
Countries
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References
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Russell SJ, Tan C, O'Keefe P, Ashraf S, Zaidi A, Fraser AG, Yousef ZR. Optimized temporary bi-ventricular pacing improves haemodynamic function after on-pump cardiac surgery in patients with severe left ventricular systolic dysfunction: a two-centre randomized control trial. Eur J Cardiothorac Surg. 2012 Dec;42(6):e146-51. doi: 10.1093/ejcts/ezs492.
Russell SJ, Tan C, O'Keefe P, Ashraf S, Zaidi A, Fraser AG, Yousef ZR. Temporary epicardial cardiac resynchronisation versus conventional right ventricular pacing after cardiac surgery: study protocol for a randomised control trial. Trials. 2012 Feb 20;13:20. doi: 10.1186/1745-6215-13-20.
Other Identifiers
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09/CAD/4628
Identifier Type: -
Identifier Source: org_study_id
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